Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00005074|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: alvocidib||Phase 2|
- Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma.
- Assess the toxicity of this regimen in this patient population.
- Determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after documented CR. Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. Patients with stable disease receive a maximum of 4 courses.
Patients are followed at 4 weeks and then every 3 months until relapse or death.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma|
|Study Start Date :||January 2000|
|Actual Study Completion Date :||September 2008|
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): NCT00005074
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Humber River Regional Hospital|
|Weston, Ontario, Canada, M9N 1N8|
|Study Chair:||Joseph M. Connors, MD||British Columbia Cancer Agency|