Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
Canada, United States