Completed

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

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What is being tested

alvocidib

Drug
Who is being recruted

DNA Virus Infections+22

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

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.

NCT00003039
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

DNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeTumor Virus InfectionsVirus DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsBurkitt LymphomaLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-Lymphoma

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.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study 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

Clinical Sciences Building

Chicago, United StatesOpen Clinical Sciences Building in Google Maps

University of Chicago Cancer Research Center

Chicago, United States

Louis A. Weiss Memorial Hospital

Chicago, United States

Cancer Care Specialists of Central Illinois, S.C.

Decatur, United States
Completed10 Study Centers