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Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

Primary Purpose

Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Conventional Surgery
Laboratory Biomarker Analysis
Sorafenib Tosylate
Temsirolimus
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after surgery as possible =< 2 prior systemic chemotherapy regimens Histological confirmation of a grade 4 astrocytoma (glioblastoma) or gliosarcoma, at primary diagnosis or recurrence by World Health Organization (WHO) criteria; central pathology review is mandatory prior to study entry to confirm eligibility Evidence of tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan following radiation therapy (RT) or following the most recent anti-tumor therapy Bidimensionally measurable or evaluable disease by MRI or CT scan Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 >= 12 weeks since the completion of RT Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 1 week prior to registration >= 1 week from minor surgery other than venous line placement and > 3 weeks from major surgery (except for patients undergoing tumor tissue acquisition) >= 4 weeks since prior cytotoxic chemotherapy (>= 6 weeks for nitrosoureas) >= 2 weeks from cytostatic chemotherapy such as tamoxifen, cis-retinoic acid, or thalidomide (address questions regarding such agents to study chair) White blood cells (WBC) >= 3,000/mm^3 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin (Hgb) >= 10 gm/dL Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN Creatinine =< 2.0 x ULN Serum cholesterol =< 350 mg/dL Serum triglycerides =< 400 mg/dL Willingness to provide the biologic specimens as required by the protocol; (please note that the willingness to participate pertains only to the patient and does not factor in the institution?s ability to participate in any part of the translational component) Exclusion Criteria: Prior intratumoral chemotherapy (e.g., Gliadel or IL13-PE38QQR), stereotactic radiosurgery, or interstitial brachytherapy unless there is a separate lesion on MRI which is not part of the previous treatment field or there is proof of recurrent disease based on biopsy, MRI spectroscopy, or positron emission tomography (PET) scan Prior CCI-779, sorafenib, or other agents specifically targeting mammalian target of rapamycin (mTOR) or raf; patients receiving prior agents inhibiting VEGF or VEGF receptor (R) (prior anti-VEGF group) are eligible but: 1) must be at least four weeks from last treatment with the agent(s); and 2) must have recovered from any clinically relevant toxicities attributable to this agent(s) Evidence of bleeding diathesis or coagulopathy Note: Patients on prophylactic anticoagulation therapy (e.g., low-dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (International Normalized Ratio [INR] of prothrombin time) < 1.1 x institutional upper limit of normal Note: Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met: a) the patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, and b) the patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) International normalized ration (INR) > 1.5 (unless the patient is on full-dose warfarin) Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone) or any other potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer, such as rifampin or St. John?s wort Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills Hypertension with systolic blood pressure of > 140 mmHg or diastolic pressure > 90 mmHg; however, patients with well-controlled hypertension are eligible Uncontrolled infection Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Known hypersensitivity to any of the components of CCI-779 or sorafenib Other active malignancy Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situation that would preclude study compliance with study requirements Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive; HIV-positive patients on combination antiretroviral therapy are ineligible Receiving any investigational agents other than CCI-779 and sorafenib Significant intratumoral, intracerebral, or subarachnoid hemorrhage on baseline MRI or CT, or other history of significant intratumoral, intracerebral, or subarachnoid hemorrhage

Sites / Locations

  • Providence Alaska Medical Center
  • Mayo Clinic in Arizona
  • Smilow Cancer Hospital Care Center at Saint Francis
  • Mayo Clinic in Florida
  • Saint Alphonsus Cancer Care Center-Boise
  • Rush - Copley Medical Center
  • Saint Joseph Medical Center
  • Illinois CancerCare-Bloomington
  • Graham Hospital Association
  • Illinois CancerCare-Canton
  • Illinois CancerCare-Carthage
  • Memorial Hospital
  • Rush University Medical Center
  • Heartland Cancer Research NCORP
  • Saint Anthony Memorial Hospital
  • Eureka Hospital
  • Illinois CancerCare-Eureka
  • Galesburg Cottage Hospital
  • Illinois CancerCare-Galesburg
  • Illinois CancerCare-Havana
  • Mason District Hospital
  • Hopedale Medical Complex - Hospital
  • Joliet Oncology-Hematology Associates Limited
  • Illinois CancerCare-Kewanee Clinic
  • Kewanee Hospital
  • Illinois CancerCare-Macomb
  • Mcdonough District Hospital
  • Holy Family Medical Center
  • Illinois CancerCare-Monmouth
  • Bromenn Regional Medical Center
  • Community Cancer Center Foundation
  • Illinois CancerCare-Community Cancer Center
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Regional Hospital and Healthcare Center
  • Illinois CancerCare-Pekin
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • Pekin Hospital
  • Methodist Medical Center of Illinois
  • Proctor Hospital
  • Illinois CancerCare-Peoria
  • OSF Saint Francis Medical Center
  • Illinois CancerCare-Peru
  • Illinois Valley Hospital
  • Illinois CancerCare-Princeton
  • Perry Memorial Hospital
  • Illinois CancerCare-Spring Valley
  • Saint Margaret's Hospital
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Franciscan Saint Anthony Health-Michigan City
  • McFarland Clinic PC-William R Bliss Cancer Center
  • Mercy Hospital
  • Oncology Associates at Mercy Medical Center
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Capitol
  • Iowa Methodist Medical Center
  • Iowa-Wide Oncology Research Coalition NCORP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates-Laurel
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • Mercy Medical Center - North Iowa
  • Siouxland Regional Cancer Center
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • Hospital District Sixth of Harper County
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Southwest Medical Center
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Via Christi Regional Medical Center
  • Wichita NCI Community Oncology Research Program
  • Cancer Center of Kansas - Winfield
  • Michigan Cancer Research Consortium NCORP
  • Saint Joseph Mercy Hospital
  • Bronson Battle Creek
  • Spectrum Health Big Rapids Hospital
  • Beaumont Hospital-Dearborn
  • Saint John Hospital and Medical Center
  • Green Bay Oncology - Escanaba
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Genesys Regional Medical Center-West Flint Campus
  • Cancer Research Consortium of West Michigan NCORP
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Green Bay Oncology - Iron Mountain
  • Allegiance Health
  • Sparrow Hospital
  • Saint Mary Mercy Hospital
  • Mercy Health Mercy Campus
  • Saint Joseph Mercy Oakland
  • Lake Huron Medical Center
  • Saint Mary's of Michigan
  • Munson Medical Center
  • Saint John Macomb-Oakland Hospital
  • Metro Health Hospital
  • Medini, Eitan MD (UIA Investigator)
  • Sanford Clinic North-Bemidgi
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Essentia Health Cancer Center
  • Essentia Health Saint Mary's Medical Center
  • Miller-Dwan Hospital
  • Fairview-Southdale Hospital
  • Etzell, Paul S MD (UIA Investigator)
  • Lake Region Healthcare Corporation-Cancer Care
  • Swenson, Wade II, MD (UIA Investigator)
  • Unity Hospital
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Minnesota Cooperative Group Outreach Program
  • Virginia Piper Cancer Institute
  • Hennepin County Medical Center
  • New Ulm Medical Center
  • North Memorial Medical Health Center
  • Mayo Clinic
  • Coborn Cancer Center at Saint Cloud Hospital
  • Saint Cloud Hospital
  • Metro Minnesota Community Oncology Research Consortium
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • Saint Joseph's Hospital - Healtheast
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Woodwinds Health Campus
  • Nebraska Cancer Research Center
  • Missouri Valley Cancer Consortium
  • Alegent Health Immanuel Medical Center
  • Alegent Health Bergan Mercy Medical Center
  • Alegent Health Lakeside Hospital
  • Creighton University Medical Center
  • Rutherford Hospital
  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
  • Mid Dakota Clinic
  • Saint Alexius Medical Center
  • Sanford Bismarck Medical Center
  • Roger Maris Cancer Center
  • Sanford Broadway Medical Center
  • Sanford Clinic North-Fargo
  • Altru Cancer Center
  • Lehigh Valley Hospital-Cedar Crest
  • Lehigh Valley Hospital - Muhlenberg
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Geisinger Medical Group
  • Geisinger Wyoming Valley/Henry Cancer Center
  • AnMed Health Cancer Center
  • AnMed Health Hospital
  • Saint Francis Hospital
  • Spartanburg Medical Center
  • Rapid City Regional Hospital
  • Sanford Cancer Center Oncology Clinic
  • Avera Cancer Institute
  • Avera McKennan Hospital and University Health Center
  • Medical X-Ray Center
  • Sanford USD Medical Center - Sioux Falls
  • University of Virginia Cancer Center
  • Virginia Commonwealth University/Massey Cancer Center
  • Virginia Mason Medical Center
  • Green Bay Oncology at Saint Vincent Hospital
  • Saint Vincent Hospital Cancer Center Green Bay
  • Green Bay Oncology Limited at Saint Mary's Hospital
  • Saint Vincent Hospital Cancer Center at Saint Mary's
  • Holy Family Memorial Hospital
  • Bay Area Medical Center
  • Green Bay Oncology - Oconto Falls
  • HSHS Saint Nicholas Hospital
  • Green Bay Oncology - Sturgeon Bay

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group I (sorafenib tosylate, temsirolimus)

Group II (sorafenib tosylate, temsirolimus, surgery)

Group III (sorafenib tosylate, temsirolimus, anti-VEGF)

Arm Description

Patients receive sorafenib tosylate and temsirolimus as in Phase I.

Patients receive sorafenib tosylate PO BID on days 1-8 and temsirolimus IV over 30 minutes on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib tosylate and temsirolimus as in Phase I.

Patients who have received prior anti-VEGF therapy and are not undergoing surgery receive sorafenib tosylate and temsirolimus as in Phase I.

Outcomes

Primary Outcome Measures

Progression-free Survival
The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation. If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group. The 'success' probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the 'success' probability will be calculated according to the approach of Duffy and Santner. Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

Secondary Outcome Measures

Overall Survival
The overall survival distribution will be estimated using the method of Kaplan-Meier.
Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement
The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.
Progression-free Survival
Kaplan-Meier survival curves will be used to estimate progression-time distributions.

Full Information

First Posted
May 23, 2006
Last Updated
September 21, 2018
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00329719
Brief Title
Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma
Official Title
A Phase I/II Trial of Sorafenib and CCI-779 in Patients With Recurrent Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 24, 2006 (Actual)
Primary Completion Date
February 1, 2013 (Actual)
Study Completion Date
February 2, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I/II trial studies the side effects and best dose of temsirolimus when given together with sorafenib tosylate and to see how well they work in treating patients with glioblastoma that has come back. Sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate and temsirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sorafenib tosylate with temsirolimus may kill more tumor cells.
Detailed Description
Primary Objective - Phase I (closed to accrual as of 01/11/2008): To establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants (EIACs). Phase II (closed to accrual as of 12/07/2012): To assess the efficacy of temsirolimus and sorafenib in the treatment of recurrent glioblastoma in non-EIAC patients as measured by progression-free survival status at six months (PFS6). Secondary Objectives - Phase I (closed to accrual as of 01/11/2008): I. To define the safety profile of temsirolimus and sorafenib in non-EIAC patients. II. To assess the evidence of antitumor activity. Phase II (closed to accrual as of 12/07/2012): I. To assess the safety and toxicities of temsirolimus and sorafenib in the above-noted patient populations. Outline: This is a multicenter, phase I, dose-escalation study followed by a phase II study. Phase I (Arm A): Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients are assigned to 1 of 3 treatment groups. Group 1 (Arm B): Patients receive sorafenib and temsirolimus as in phase I at the MTD. (patients not undergoing surgery) Group 2 (Arm C): Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. (patients undergoing surgery) After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD. Group 3 (Arm D): Patient receive sorafenib and temsirolimus as in phase I at the MTD. (patients who have received prior anti-vascular endothelial growth factor [VEGF] therapy and are not undergoing surgery) Biopsy or resected tissue and blood are collected prior to treatment (usually at diagnosis) and analyzed for biomarkers. After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (sorafenib tosylate, temsirolimus)
Arm Type
Experimental
Arm Description
Patients receive sorafenib tosylate and temsirolimus as in Phase I.
Arm Title
Group II (sorafenib tosylate, temsirolimus, surgery)
Arm Type
Experimental
Arm Description
Patients receive sorafenib tosylate PO BID on days 1-8 and temsirolimus IV over 30 minutes on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib tosylate and temsirolimus as in Phase I.
Arm Title
Group III (sorafenib tosylate, temsirolimus, anti-VEGF)
Arm Type
Experimental
Arm Description
Patients who have received prior anti-VEGF therapy and are not undergoing surgery receive sorafenib tosylate and temsirolimus as in Phase I.
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgery
Intervention Description
Undergo surgery
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Sorafenib Tosylate
Other Intervention Name(s)
BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Temsirolimus
Other Intervention Name(s)
CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, Torisel
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation. If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group. The 'success' probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the 'success' probability will be calculated according to the approach of Duffy and Santner. Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The overall survival distribution will be estimated using the method of Kaplan-Meier.
Time Frame
From start of study registration to death due to any cause or until last follow-up, up to 5 years
Title
Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement
Description
The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.
Time Frame
Up to 5 years
Title
Progression-free Survival
Description
Kaplan-Meier survival curves will be used to estimate progression-time distributions.
Time Frame
Time from study registration to date of disease progression or last follow-up, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after surgery as possible =< 2 prior systemic chemotherapy regimens Histological confirmation of a grade 4 astrocytoma (glioblastoma) or gliosarcoma, at primary diagnosis or recurrence by World Health Organization (WHO) criteria; central pathology review is mandatory prior to study entry to confirm eligibility Evidence of tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan following radiation therapy (RT) or following the most recent anti-tumor therapy Bidimensionally measurable or evaluable disease by MRI or CT scan Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 >= 12 weeks since the completion of RT Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 1 week prior to registration >= 1 week from minor surgery other than venous line placement and > 3 weeks from major surgery (except for patients undergoing tumor tissue acquisition) >= 4 weeks since prior cytotoxic chemotherapy (>= 6 weeks for nitrosoureas) >= 2 weeks from cytostatic chemotherapy such as tamoxifen, cis-retinoic acid, or thalidomide (address questions regarding such agents to study chair) White blood cells (WBC) >= 3,000/mm^3 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin (Hgb) >= 10 gm/dL Total bilirubin =< 1.5 x upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN Creatinine =< 2.0 x ULN Serum cholesterol =< 350 mg/dL Serum triglycerides =< 400 mg/dL Willingness to provide the biologic specimens as required by the protocol; (please note that the willingness to participate pertains only to the patient and does not factor in the institution?s ability to participate in any part of the translational component) Exclusion Criteria: Prior intratumoral chemotherapy (e.g., Gliadel or IL13-PE38QQR), stereotactic radiosurgery, or interstitial brachytherapy unless there is a separate lesion on MRI which is not part of the previous treatment field or there is proof of recurrent disease based on biopsy, MRI spectroscopy, or positron emission tomography (PET) scan Prior CCI-779, sorafenib, or other agents specifically targeting mammalian target of rapamycin (mTOR) or raf; patients receiving prior agents inhibiting VEGF or VEGF receptor (R) (prior anti-VEGF group) are eligible but: 1) must be at least four weeks from last treatment with the agent(s); and 2) must have recovered from any clinically relevant toxicities attributable to this agent(s) Evidence of bleeding diathesis or coagulopathy Note: Patients on prophylactic anticoagulation therapy (e.g., low-dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (International Normalized Ratio [INR] of prothrombin time) < 1.1 x institutional upper limit of normal Note: Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met: a) the patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, and b) the patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) International normalized ration (INR) > 1.5 (unless the patient is on full-dose warfarin) Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone) or any other potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer, such as rifampin or St. John?s wort Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills Hypertension with systolic blood pressure of > 140 mmHg or diastolic pressure > 90 mmHg; however, patients with well-controlled hypertension are eligible Uncontrolled infection Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Known hypersensitivity to any of the components of CCI-779 or sorafenib Other active malignancy Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situation that would preclude study compliance with study requirements Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive; HIV-positive patients on combination antiretroviral therapy are ineligible Receiving any investigational agents other than CCI-779 and sorafenib Significant intratumoral, intracerebral, or subarachnoid hemorrhage on baseline MRI or CT, or other history of significant intratumoral, intracerebral, or subarachnoid hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Jaeckle
Organizational Affiliation
Alliance for Clinical Trials in Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Graham Hospital Association
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Heartland Cancer Research NCORP
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Saint Anthony Memorial Hospital
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Eureka Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex - Hospital
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Limited
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Kewanee Hospital
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Mcdonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Holy Family Medical Center
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Illinois CancerCare-Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Bromenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center Foundation
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Ottawa Regional Hospital and Healthcare Center
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois Valley Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Illinois CancerCare-Spring Valley
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Saint Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Franciscan Saint Anthony Health-Michigan City
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
McFarland Clinic PC-William R Bliss Cancer Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Capitol
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa-Wide Oncology Research Coalition NCORP
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Hospital District Sixth of Harper County
City
Anthony
State/Province
Kansas
ZIP/Postal Code
67003
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wichita NCI Community Oncology Research Program
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Michigan Cancer Research Consortium NCORP
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Spectrum Health Big Rapids Hospital
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Beaumont Hospital-Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Green Bay Oncology - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49829
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Regional Medical Center-West Flint Campus
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Cancer Research Consortium of West Michigan NCORP
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Green Bay Oncology - Iron Mountain
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Mercy Health Mercy Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Lake Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Saint Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Medini, Eitan MD (UIA Investigator)
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Facility Name
Sanford Clinic North-Bemidgi
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Essentia Health Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Essentia Health Saint Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller-Dwan Hospital
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview-Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Etzell, Paul S MD (UIA Investigator)
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Lake Region Healthcare Corporation-Cancer Care
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Swenson, Wade II, MD (UIA Investigator)
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minnesota Cooperative Group Outreach Program
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Coborn Cancer Center at Saint Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Saint Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Metro Minnesota Community Oncology Research Consortium
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Saint Joseph's Hospital - Healtheast
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Woodwinds Health Campus
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Nebraska Cancer Research Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Alegent Health Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Alegent Health Lakeside Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Saint Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Clinic North-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Cancer Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Medical Center-Cancer Center Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Geisinger Medical Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
AnMed Health Hospital
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Avera McKennan Hospital and University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Green Bay Oncology at Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology Limited at Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Saint Mary's
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Holy Family Memorial Hospital
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Green Bay Oncology - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
HSHS Saint Nicholas Hospital
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Green Bay Oncology - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

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