NCT00005971

Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	alvocidib

Timeline

• Start date: 2000-07-04
• Primary completion: 2001-08-24
• Completion: 2009-12-21
• First posted: 2003-05-21
• Last updated: 2020-04-09

Locations

50 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study