Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: alvocidib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alvocidib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma