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Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00003620
Collaborator
(none)
37
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia.

Assess the toxicity profile of this treatment in these patients. Examine progression-free survival and overall survival following this treatment in these patients.

Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in these patients.

OUTLINE: This is an open label, multicenter study.

Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for the first year and then every 6 months for 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA
Study Start Date :
Jun 1, 1999
Actual Primary Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (flavopiridol)

Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity. Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.

Drug: alvocidib
Given IV
Other Names:
  • FLAVO
  • flavopiridol
  • HMR 1275
  • L-868275

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Complete + partial response rate [Up to 5 years]

      The CR + PR rate will be estimated with a 95% confidence interval, and the success of the study will be judged with the two-stage design given above.

    Secondary Outcome Measures

    1. Toxicity profile of flavopiridol [Up to 5 years]

      Toxicities will be tabulated by type and grade

    2. Progression-free survival [From onstudy date to the date of progression or death, assessed up to 5 years]

      Will be estimated using the Kaplan-Meier method.

    3. Overall survival [From onstudy date to the date of death, assessed up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or
    1. refractory B-cell chronic lymphocytic leukemia

    • Intermediate risk group must have evidence of active disease as shown by at least one of the following:

    • Massive or progressive splenomegaly and/or lymphadenopathy

    • Weight loss of greater than 10% in the last 6 months

    • CALGB grade 2-4 fatigue

    • Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection

    • Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months

    • Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine

    • Lymphocytosis greater than 5000/mm3 at some time during disease

    • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

    • Creatinine no greater than 1.5 times ULN

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab)

    • At least 1, but no more than 3, prior chemotherapy regimens

    • At least 1 prior chemotherapy regimen comprising fludarabine

    • No other concurrent chemotherapy

    • No concurrent chronic use of oral corticosteroids

    • No concurrent hormone therapy except for non-disease related conditions

    • No concurrent dexamethasone or other corticosteroid-based antiemetics

    • No concurrent palliative radiotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer and Leukemia Group B Chicago Illinois United States 60606

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: John Byrd, Cancer and Leukemia Group B

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00003620
    Other Study ID Numbers:
    • NCI-2012-02280
    • CALGB-19805
    • U10CA031946
    • CDR0000066699
    First Posted:
    Sep 25, 2003
    Last Update Posted:
    Jan 17, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Alvocidib

    Study Results

    No Results Posted as of Jan 17, 2013