Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
OBJECTIVES:
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Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma.
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Assess the toxicity of this regimen in this patient population.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy
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No documented disease progression while receiving prior chemotherapy
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CD20 and CD5 positive
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Presence of clinically and/or radiologically documented disease
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At least 1 site of disease must be bidimensionally measurable
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Bone lesions not considered bidimensionally measurable
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Minimum indicator lesions must be:
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Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR
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Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam
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No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
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Absolute granulocyte count at least 1,500/mm3
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Platelet count at least 75,000/mm3
Hepatic:
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Bilirubin no greater than 1.5 times upper limit or normal (ULN)
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AST no greater than 2.5 times ULN
Renal:
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Creatinine no greater than 1.5 times ULN OR
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Creatinine clearance at least 60 mL/min
Cardiovascular:
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No clinically significant cardiac symptomatology
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If history of cardiac disease, cardiac ejection fraction greater than 50%
Pulmonary:
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No clinically significant pulmonary symptomatology
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If history of symptomatic pulmonary disease:
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FEV1, FVC, and TLC greater than 60% predicted
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DLCO greater than 50% predicted
Other:
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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Must be accessible for treatment and follow-up (i.e., no geographical limitations)
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No uncontrolled bacterial, fungal, or viral infection
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No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
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No prior radioactive monoclonal antibody therapy
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Prior rituximab allowed
Chemotherapy:
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See Disease Characteristics
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No more than 2 prior chemotherapy regimens allowed
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Same chemotherapy combination given for first line and second line therapy considered 2 regimens
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At least 6 weeks since prior chemotherapy
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No prior high-dose chemotherapy and stem cell transplantation
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No other concurrent cytotoxic chemotherapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
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No prior radiotherapy to greater than 25% of functioning bone marrow
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At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
2 | Cancer Care Ontario-Hamilton Regional Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
3 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
4 | Humber River Regional Hospital | Weston | Ontario | Canada | M9N 1N8 |
Sponsors and Collaborators
- NCIC Clinical Trials Group
Investigators
- Study Chair: Joseph M. Connors, MD, British Columbia Cancer Agency
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I127
- CAN-NCIC-IND127
- NCI-100
- CDR0000067679