Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma
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.
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.
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