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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Metastatic Melanoma  CCI-779 in Treating Patients With Metastatic Melanoma
CCI-779 in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): Beckman Research Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimMargolin, Study Chair, Beckman Research Institute
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089
United States
City of Hope Medical Group
Pasadena, California, 91105
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-0269
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000068820; CHNMC-PHII-27,NCI-29,CHNMC-IRB-99167
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022464
Other Stage 4 Melanoma Studies:
1. Biological Therapy in Treating Patients With Metastatic Melanoma
2. Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
3. Boron Neutron Capture Therapy in Treating Patients With Melanoma
4. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
5. Interferon alfa and Thalidomide in Treating Patients With Stage IV Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
CCI-779 in Treating Patients With Metastatic Melanoma
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