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Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

Primary Purpose

Recurrent Melanoma, Stage IV Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
tipifarnib
temsirolimus
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Melanoma

Eligibility Criteria

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

Criteria: Histologically confirmed malignant melanoma of cutaneous origin Patients with unknown primary allowed Stage IV disease Measurable disease by physical examination, CT scan, MRI or plain x-ray Unresectable disease Residual or recurrent disease after prior surgery for stage IV disease allowed Residual tumor at the site of incomplete resection may be included only as nonmeasurable disease Must have serum lactate dehydrogenase (LDH) levels measured Must have tissue specimens available Negative brain CT scan or MRI within the past 42 days Creatinine =< 1.5 times ULN Absolute neutrophil count >= 1,000/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin >= 9.0 g/dL Fasting cholesterol =< 350 mg/dL (lipid-lowering agents allowed) Triglycerides =< 300 mg/dL (lipid-lowering agents allowed) No symptomatic sensory neuropathy >= grade 2 No evidence of bleeding diathesis or coagulopathy No congestive heart failure No myocardial infarction within the past 2 months No New York Heart Association class III or IV heart disease No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease) No known allergy to imidazoles (e.g. clotrimazole, ketoconazole, miconazole, or econazole) No history of allergic reaction to compounds of similar chemical or biologic composition as tipifarnib No hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg Patients with well-controlled hypertension allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled diabetes No uncontrolled diabetes No active uncontrolled infection No other severe or uncontrolled medical disease No psychologic or medical condition that would preclude study treatment or compliance No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer that is in complete remission, or carcinoma in situ of the cervix At least 90 days since prior adjuvant therapy, including cytotoxic agents At least 28 days since prior radiotherapy At least 28 days since prior surgery to remove the tumor No prior systemic therapy for stage IV melanoma No prior therapy with agents targeting farnesyl transferase, the MAP kinase pathway, or vascular endothelial growth factors (VEGF) or receptors (VEFGR), including drugs such as sorafenib, temsirolimus, or tipifarnib Concurrent lipid-lowering agents allowed Not requiring full-dose anticoagulation for recent thrombotic event No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients No concurrent use of any of the following: dilantin; carbamazepine; Phenobarbital; rifampin; hypericum perforatum (St. John's wort); ketoconazole; itraconazole; ritonavir; cyclosporine; phenytoin; grapefruit juice Bilirubin =< 1.5 times upper limit of normal (ULN) SGOT or SGPT =< 2.5 times ULN (5 times ULN if hepatic metastases) No history of brain metastases Zubrod performance status 0-1

Sites / Locations

  • University of Arkansas for Medical Sciences
  • East Bay Radiation Oncology Center
  • Eden Hospital Medical Center
  • Valley Medical Oncology Consultants-Castro Valley
  • Valley Medical Oncology Consultants-Fremont
  • University of Southern California/Norris Cancer Center
  • Contra Costa Regional Medical Center
  • El Camino Hospital
  • Highland General Hospital
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Breast Surgeons Inc
  • Bay Area Tumor Institute CCOP
  • Larry G Strieff MD Medical Corporation
  • Tom K Lee Inc
  • Valley Care Health System - Pleasanton
  • Valley Medical Oncology Consultants
  • Sutter Roseville Medical Center
  • Sutter General Hospital
  • Doctors Medical Center- JC Robinson Regional Cancer Center
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Exempla Saint Joseph Hospital
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Rose Medical Center
  • Colorado Cancer Research Program CCOP
  • Swedish Medical Center
  • Saint Mary's Hospital and Regional Medical Center
  • North Colorado Medical Center
  • Saint Anthony Hospital
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • McKee Medical Center
  • Saint Mary Corwin Medical Center
  • North Suburban Medical Center
  • Exempla Lutheran Medical Center
  • Cancer Centers of Central Florida PA
  • Northeast Georgia Medical Center
  • Memorial Health University Medical Center
  • South Georgia Medical Center
  • Rush - Copley Medical Center
  • Decatur Memorial Hospital
  • Joliet Oncology-Hematology Associates Limited
  • Loyola University Medical Center
  • Garneau, Stewart C MD (UIA Investigator)
  • Porubcin, Michael MD (UIA Investigator)
  • Sharis, Christine M MD (UIA Investigator)
  • Stoffel, Thomas J MD (UIA Investigator)
  • Memorial Medical Center
  • Carle Cancer Center
  • Carle Clinic-Urbana Main
  • Franciscan Saint Anthony Health-Michigan City
  • McFarland Clinic PC-William R Bliss Cancer Center
  • Constantinou, Costas L MD (UIA Investigator)
  • Medical Oncology and Hematology Associates-West Des Moines
  • Genesis Medical Center - East Campus
  • Genesis Medical Center - West Campus
  • Mercy Capitol
  • Iowa Methodist Medical Center
  • Iowa Oncology Research Association CCOP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates-Laurel
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • Siouxland Hematology Oncology Associates
  • 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
  • Hays Medical Center
  • Promise Regional Medical Center-Hutchinson
  • Cancer Center of Kansas-Independence
  • Providence Medical Center
  • University of Kansas Medical Center
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas - Newton
  • Olathe Cancer Center
  • Radiation Oncology Practice Corporation Southwest
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Stormont-Vail Regional Health Center
  • Saint Francis Hospital and Medical Center - Topeka
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Main Office
  • Via Christi Regional Medical Center
  • Wichita CCOP
  • Cancer Center of Kansas - Winfield
  • Louisiana State University Sciences Center- Monroe
  • Highland Clinic
  • Louisiana State University Health Sciences Center Shreveport
  • Boston Medical Center
  • University of Michigan
  • Bronson Battle Creek
  • Spectrum Health Big Rapids Hospital
  • Wayne State University/Karmanos Cancer Institute
  • Henry Ford Hospital
  • Grand Rapids Clinical Oncology Program
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Holland Community Hospital
  • Mercy Health Partners-Hackley Campus
  • Mercy Health Mercy Campus
  • Munson Medical Center
  • Metro Health Hospital
  • Meeker County Memorial Hospital
  • Virginia Piper Cancer Institute
  • Southeast Missouri Hospital
  • Centerpoint Medical Center LLC
  • Radiation Oncology Practice Corporation South
  • Radiation Oncology Practice Corporation - North
  • Montana Cancer Consortium CCOP
  • Northern Rockies Radiation Oncology Center
  • Saint Vincent Healthcare
  • Hematology-Oncology Centers of the Northern Rockies PC
  • Billings Clinic
  • Bozeman Deaconess Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Berdeaux, Donald MD (UIA Investigator)
  • Great Falls Clinic
  • Northern Montana Hospital
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Community Medical Hospital
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Guardian Oncology and Center for Wellness
  • Good Samaritan Hospital
  • Nebraska Cancer Research Center
  • University Medical Center of Southern Nevada
  • Nevada Cancer Research Foundation CCOP
  • Mary Imogene Bassett Hospital
  • Orange Regional Medical Center
  • Mission Hospital-Memorial Campus
  • Rutherford Hospital
  • University of Cincinnati
  • Mansfield General Hospital-MedCentral Health System
  • Adventist Medical Center
  • SWOG
  • Delaware County Memorial Hospital
  • Thomas Jefferson University Hospital
  • AnMed Health Hospital
  • Spartanburg Regional Medical Center
  • Upstate Carolina CCOP
  • Huntsman Cancer Institute/University of Utah
  • Danville Regional Medical Center
  • Southwest VA Regional Cancer Center
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Columbia Basin Hematology and Oncology PLLC
  • Skagit Valley Hospital
  • Harborview Medical Center
  • Minor and James Medical PLLC
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • Group Health Cooperative-Seattle
  • Swedish Medical Center-First Hill
  • The Polyclinic
  • University of Washington Medical Center
  • United General Hospital
  • Cancer Care Northwest - Spokane South
  • Wenatchee Valley Medical Center
  • Dean Hematology and Oncology Clinic
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (sorafenib, temsirolimus)

Arm II (sorafenib, tipifarnib)

Arm Description

Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21

Outcomes

Primary Outcome Measures

Response Rate (Complete and Partial)
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
4-month Progression-free Survival
Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.

Secondary Outcome Measures

One-year Overall Survival
Toxicity
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

Full Information

First Posted
January 24, 2006
Last Updated
May 2, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00281957
Brief Title
Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery
Official Title
A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.
Detailed Description
PRIMARY OBJECTIVES: I. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib. II. Compare the 4-month progression-free survival rate of patients treated with these regimens. III. Compare the safety and tolerability of these regimens, with an emphasis on long-term side effects and toxic effects, in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms. ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma, Stage IV Melanoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm I (sorafenib, temsirolimus)
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Arm Title
Arm II (sorafenib, tipifarnib)
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
tipifarnib
Other Intervention Name(s)
R115777, Zarnestra
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
temsirolimus
Other Intervention Name(s)
CCI-779, cell cycle inhibitor 779, Torisel
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response Rate (Complete and Partial)
Description
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
Time Frame
Every 8 weeks until progression
Title
4-month Progression-free Survival
Description
Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.
Time Frame
4 months after registration
Secondary Outcome Measure Information:
Title
One-year Overall Survival
Time Frame
One year after registration
Title
Toxicity
Description
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Time Frame
Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Histologically confirmed malignant melanoma of cutaneous origin Patients with unknown primary allowed Stage IV disease Measurable disease by physical examination, CT scan, MRI or plain x-ray Unresectable disease Residual or recurrent disease after prior surgery for stage IV disease allowed Residual tumor at the site of incomplete resection may be included only as nonmeasurable disease Must have serum lactate dehydrogenase (LDH) levels measured Must have tissue specimens available Negative brain CT scan or MRI within the past 42 days Creatinine =< 1.5 times ULN Absolute neutrophil count >= 1,000/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin >= 9.0 g/dL Fasting cholesterol =< 350 mg/dL (lipid-lowering agents allowed) Triglycerides =< 300 mg/dL (lipid-lowering agents allowed) No symptomatic sensory neuropathy >= grade 2 No evidence of bleeding diathesis or coagulopathy No congestive heart failure No myocardial infarction within the past 2 months No New York Heart Association class III or IV heart disease No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease) No known allergy to imidazoles (e.g. clotrimazole, ketoconazole, miconazole, or econazole) No history of allergic reaction to compounds of similar chemical or biologic composition as tipifarnib No hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg Patients with well-controlled hypertension allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled diabetes No uncontrolled diabetes No active uncontrolled infection No other severe or uncontrolled medical disease No psychologic or medical condition that would preclude study treatment or compliance No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer that is in complete remission, or carcinoma in situ of the cervix At least 90 days since prior adjuvant therapy, including cytotoxic agents At least 28 days since prior radiotherapy At least 28 days since prior surgery to remove the tumor No prior systemic therapy for stage IV melanoma No prior therapy with agents targeting farnesyl transferase, the MAP kinase pathway, or vascular endothelial growth factors (VEGF) or receptors (VEFGR), including drugs such as sorafenib, temsirolimus, or tipifarnib Concurrent lipid-lowering agents allowed Not requiring full-dose anticoagulation for recent thrombotic event No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients No concurrent use of any of the following: dilantin; carbamazepine; Phenobarbital; rifampin; hypericum perforatum (St. John's wort); ketoconazole; itraconazole; ritonavir; cyclosporine; phenytoin; grapefruit juice Bilirubin =< 1.5 times upper limit of normal (ULN) SGOT or SGPT =< 2.5 times ULN (5 times ULN if hepatic metastases) No history of brain metastases Zubrod performance status 0-1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Margolin
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay Radiation Oncology Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Eden Hospital Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology Consultants-Castro Valley
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology Consultants-Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
University of Southern California/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Highland General Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Breast Surgeons Inc
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Tumor Institute CCOP
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Larry G Strieff MD Medical Corporation
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Tom K Lee Inc
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Valley Care Health System - Pleasanton
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Valley Medical Oncology Consultants
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Doctors Medical Center- JC Robinson Regional Cancer Center
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Exempla Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Cancer Research Program CCOP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224-2522
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Cancer Centers of Central Florida PA
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34788
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403
Country
United States
Facility Name
South Georgia Medical Center
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31603
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Limited
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Garneau, Stewart C MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Porubcin, Michael MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Sharis, Christine M MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Stoffel, Thomas J MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Carle Clinic-Urbana Main
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
Constantinou, Costas L MD (UIA Investigator)
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
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
Genesis Medical Center - East Campus
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Genesis Medical Center - West Campus
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52804
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 Oncology Research Association CCOP
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
Siouxland Hematology Oncology Associates
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
Hays Medical Center
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Promise Regional Medical Center-Hutchinson
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
65702
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Providence Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
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
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Olathe Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Radiation Oncology Practice Corporation Southwest
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
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
Stormont-Vail Regional Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Saint Francis Hospital and Medical Center - Topeka
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
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 - Main Office
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 CCOP
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
Louisiana State University Sciences Center- Monroe
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71210
Country
United States
Facility Name
Highland Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Louisiana State University Health Sciences Center Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
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
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
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
Holland Community Hospital
City
Holland
State/Province
Michigan
ZIP/Postal Code
49423
Country
United States
Facility Name
Mercy Health Partners-Hackley Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49442
Country
United States
Facility Name
Mercy Health Mercy Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Southeast Missouri Hospital
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Radiation Oncology Practice Corporation South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Radiation Oncology Practice Corporation - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Montana Cancer Consortium CCOP
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies PC
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Berdeaux, Donald MD (UIA Investigator)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Good Samaritan Hospital
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
Country
United States
Facility Name
Nebraska Cancer Research Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Nevada Cancer Research Foundation CCOP
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Mary Imogene Bassett Hospital
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940
Country
United States
Facility Name
Mission Hospital-Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Mansfield General Hospital-MedCentral Health System
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Adventist Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97216
Country
United States
Facility Name
SWOG
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
AnMed Health Hospital
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Upstate Carolina CCOP
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Southwest VA Regional Cancer Center
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Columbia Basin Hematology and Oncology PLLC
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Cooperative-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
United General Hospital
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Dean Hematology and Oncology Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

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