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Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alvocidib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Sciences Building
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Cancer Care Specialists of Central Illinois, S.C.
  • Evanston Northwestern Health Care
  • Lutheran General Hospital
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • Michiana Hematology/Oncology P.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 4, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003039
Brief Title
Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
alvocidib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M. Zimmerman, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Sciences Building
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Michiana Hematology/Oncology P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States

12. IPD Sharing Statement

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Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

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