Lymphoma Clinical Trial
Official title:
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With 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.
OBJECTIVES:
- 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.
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