Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
|ClinicalTrials.gov Identifier: NCT00005971|
Recruitment Status : Completed
First Posted : May 21, 2003
Last Update Posted : November 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: alvocidib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma|
|Study Start Date :||July 2000|
|Study Completion Date :||December 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005971
Show 50 Study Locations
|Study Chair:||Susan Burdette-Radoux, MD||McGill Cancer Centre at McGill University|