- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005074
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Weston, Ontario, Canada, M9N 1N8
- Humber River Regional Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Joseph M. Connors, MD, British Columbia Cancer Agency
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Alvocidib
Other Study ID Numbers
- I127
- CAN-NCIC-IND127 (Other Identifier: PDQ)
- NCI-100 (Other Identifier: NCI)
- CDR0000067679 (Other Identifier: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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