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CompletedNCT00003039Updated Feb 5, 2013

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

A Phase 2 interventional study of alvocidib in Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-05.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    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.

    Drug: alvocidib

Interventions

  • Drugalvocidib
06

Study locations

10 sites
  • Clinical Sciences Building
    Chicago, Illinois 60612, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637, United States
  • Louis A. Weiss Memorial Hospital
    Chicago, Illinois 60640, United States
  • Cancer Care Specialists of Central Illinois, S.C.
    Decatur, Illinois 62526, United States
  • Evanston Northwestern Health Care
    Evanston, Illinois 60201, United States
  • Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
  • Oncology/Hematology Associates of Central Illinois, P.C.
    Peoria, Illinois 61602, United States
  • Central Illinois Hematology Oncology Center
    Springfield, Illinois 62701, United States
  • Fort Wayne Medical Oncology and Hematology, Inc.
    Fort Wayne, Indiana 46885-5099, United States
  • Michiana Hematology/Oncology P.C.
    South Bend, Indiana 46617, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00003039
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 6, 2004
Start date
Sep 1997
Primary completion
Apr 2000
Last update
Feb 5, 2013

Study contacts

Todd M. Zimmerman, MD
study chair · University of Chicago
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2000. You cannot join it, but the record below documents what was studied.

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