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CCI-779 in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
temsirolimus
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Progressive disease No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 4 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed) Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A reductase inhibitors Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No prior allergic reactions to compounds of similar chemical or biological composition to study drug No ongoing or active infection No seizure disorder No autoimmune disease No psychiatric illness or social situation that would preclude study No other concurrent uncontrolled illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior adjuvant biological therapy regimen No more than 1 prior biological therapy regimen for advanced disease At least 6 months since prior biological therapy or biochemotherapy and recovered Prior isolated limb perfusion with biological agent allowed if not to sole site of disease Chemotherapy: See Biologic therapy Prior isolated limb perfusion with chemotherapy allowed if not to sole site of disease No more than 1 prior chemotherapy-containing regimen for advanced disease, regardless of adjuvant therapy May be in addition to 1 prior biologic regimen for advanced disease OR May have had 1 prior biochemotherapy regimen for advanced disease At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior dexamethasone No concurrent glucocorticosteroid therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin At least 3 weeks since other prior agents to treat malignancy At least 3 weeks since prior investigational agents No other concurrent investigational agents No concurrent drugs that are metabolized by or alter the level of cytochrome P450-3A

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • City of Hope Medical Group
  • University of California Davis Cancer Center
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Decatur Memorial Hospital Cancer Care Institute
  • Evanston Northwestern Health Care - Evanston Hospital
  • Ingalls Memorial Hospital
  • LaGrange Memorial Hospital
  • Loyola University Medical Center
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • North Shore University Hospital
  • Weill Medical College of Cornell University
  • Abramson Cancer Center of the University of Pennsylvania
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
June 3, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022464
Brief Title
CCI-779 in Treating Patients With Metastatic Melanoma
Official Title
A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma.
Detailed Description
OBJECTIVES: Determine the anti-tumor activity of CCI-779, in terms of progression-free survival, in patients with metastatic melanoma. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive CCI-779 IV over 30 minutes on day 1. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: Approximately 40-50 patients will be accrued for this study within 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temsirolimus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Progressive disease No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 4 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Cholesterol no greater than 350 mg/dL (lipid-lowering therapy allowed) Triglycerides no greater than 300 mg/dL except for hydroxymethyl-glutaryl-coenzyme A reductase inhibitors Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No prior allergic reactions to compounds of similar chemical or biological composition to study drug No ongoing or active infection No seizure disorder No autoimmune disease No psychiatric illness or social situation that would preclude study No other concurrent uncontrolled illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior adjuvant biological therapy regimen No more than 1 prior biological therapy regimen for advanced disease At least 6 months since prior biological therapy or biochemotherapy and recovered Prior isolated limb perfusion with biological agent allowed if not to sole site of disease Chemotherapy: See Biologic therapy Prior isolated limb perfusion with chemotherapy allowed if not to sole site of disease No more than 1 prior chemotherapy-containing regimen for advanced disease, regardless of adjuvant therapy May be in addition to 1 prior biologic regimen for advanced disease OR May have had 1 prior biochemotherapy regimen for advanced disease At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: At least 1 week since prior dexamethasone No concurrent glucocorticosteroid therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin At least 3 weeks since other prior agents to treat malignancy At least 3 weeks since prior investigational agents No other concurrent investigational agents No concurrent drugs that are metabolized by or alter the level of cytochrome P450-3A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim A. Margolin, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-0269
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
City of Hope Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
LaGrange Memorial Hospital
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16007689
Citation
Margolin K, Longmate J, Baratta T, Synold T, Christensen S, Weber J, Gajewski T, Quirt I, Doroshow JH. CCI-779 in metastatic melanoma: a phase II trial of the California Cancer Consortium. Cancer. 2005 Sep 1;104(5):1045-8. doi: 10.1002/cncr.21265.
Results Reference
result

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CCI-779 in Treating Patients With Metastatic Melanoma

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