Melanoma (Skin)
Conditions
Keywords
stage IV 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 flavopiridol in treating patients who have metastatic malignant melanoma.
Detailed description
OBJECTIVES: * Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma. * Assess the toxicity of this treatment in these patients. * Assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen. OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, and then every 3 months until disease progression or death. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Interventions
DRUGalvocidib
Sponsors
NCIC Clinical Trials Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic malignant melanoma not amenable to standard curative therapies * No prior regional or systemic therapy for metastatic disease * Measurable disease * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Bone lesions not considered measurable * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 2.5 times ULN Renal: * Creatinine no greater than ULN Cardiovascular: * If history of cardiac disease, ejection fraction greater than 50% * No clinically significant cardiac symptomology Pulmonary: * If history of pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted * No clinically significant pulmonary symptomology Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent serious disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior adjuvant immunotherapy allowed * No prior immunotherapy for metastatic disease Chemotherapy: * No prior chemotherapy for metastatic disease * No other concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior adjuvant hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * Must have measurable disease outside irradiated area OR * Evidence of progression or new lesions in irradiated area * No more than 25% of functioning bone marrow irradiated * No concurrent radiotherapy to sole site of measurable disease Surgery: * At least 4 weeks since prior major surgery Other: * No other concurrent anticancer therapy or investigational anticancer agents
Countries
Canada
Outcome results
None listed