Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
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|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|
|Actual Study Completion Date :||December 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005971
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|Study Chair:||Susan Burdette-Radoux, MD||McGill Cancer Centre at McGill University|