Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: alvocidib


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy No documented disease progression while receiving prior chemotherapy CD20 and CD5 positive Presence of clinically and/or radiologically documented disease At least 1 site of disease must be bidimensionally measurable Bone lesions not considered bidimensionally measurable Minimum indicator lesions must be: Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit or normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No clinically significant cardiac symptomatology If history of cardiac disease, cardiac ejection fraction greater than 50% Pulmonary: No clinically significant pulmonary symptomatology If history of symptomatic pulmonary disease: FEV1, FVC, and TLC greater than 60% predicted DLCO greater than 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be accessible for treatment and follow-up (i.e., no geographical limitations) No uncontrolled bacterial, fungal, or viral infection No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: No prior radioactive monoclonal antibody therapy Prior rituximab allowed Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens allowed Same chemotherapy combination given for first line and second line therapy considered 2 regimens At least 6 weeks since prior chemotherapy No prior high-dose chemotherapy and stem cell transplantation No other concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiotherapy to greater than 25% of functioning bone marrow At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered No concurrent radiotherapy to sole site of measurable disease Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational anticancer agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alvocidib|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, stage II mantle cell lymphoma