Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
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.
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Completion Date:||September 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|