Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: alvocidib |
Phase 2 |
| Study Type: | Interventional |
| 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| 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 |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005074 History of Changes |
| Other Study ID Numbers: | I127, CAN-NCIC-IND127, NCI-100, CDR0000067679 |
| Study First Received: | April 6, 2000 |
| Last Updated: | November 7, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by NCIC Clinical Trials Group:
|
stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma stage II mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Flavopiridol |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013