Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
NCT ID: NCT00003039
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1997-09-30
Brief Summary
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Detailed Description
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I. Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkin's lymphoma and mantle cell lymphoma.
II. Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients.
III. Study the pharmacokinetics of flavopiridol in these patients.
OUTLINE: This is an open label, multi-institutional study.
Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs. Patients are followed until death.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs.
alvocidib
Interventions
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alvocidib
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma with clinical or pathological evidence of recurrent disease
* Measurable or evaluable disease
* CNS metastases not requiring intravenous steroid therapy allowed
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: CALGB 0-2
* Life expectancy: At least 12 weeks
* Absolute neutrophil count at least 1500/mm3 (unless due to bone marrow involvement by lymphoma)
* Platelet count at least 100,000/mm3 (unless due to bone marrow involvement by lymphoma)
* At least 7 days since platelet transfusion
* Hemoglobin at least 9.0 g/dL
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
* No significant uncontrolled medical or psychiatric illness
* No active serious infection
* Not pregnant or lactating
* Fertile patients must use effective contraception
* Central venous catheter required prior to study entry
PRIOR CONCURRENT THERAPY:
* No more than 1 prior chemotherapy regimen
* At least 4 weeks since prior chemotherapy and recovered from all toxic effects Prior chemotherapy must contain anthracycline if intermediate or high-grade NHL other than mantle cell
* No concurrent treatment with other chemotherapeutic or investigational antineoplastic drugs
* At least 4 weeks since prior radiation therapy and recovered (Site of only measurable disease must not be located within prior radiation therapy port)
* No concurrent radiation therapy to any lesion
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Todd M. Zimmerman, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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Clinical Sciences Building
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Lutheran General Hospital
Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States
Countries
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Other Identifiers
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UCCRC-8548
Identifier Type: -
Identifier Source: secondary_id
NCI-T96-0099
Identifier Type: -
Identifier Source: secondary_id
CDR0000065663
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02253
Identifier Type: -
Identifier Source: org_study_id
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