A Phase II Trial of Flavopiridol (NSC 649890) Administered as a 72-Hour Continuous Infusion Every 2 Weeks in Patients With Previously Treated Intermediate and High Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma
alvocidib
DNA Virus Infections+22
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Treatment Study
Summary
Study start date: September 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
University of Chicago Cancer Research Center
Chicago, United StatesLouis A. Weiss Memorial Hospital
Chicago, United StatesCancer Care Specialists of Central Illinois, S.C.
Decatur, United States