Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma

Sponsor
NCIC Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00005074
Collaborator
(none)
33
4
104
8.3
0.1

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:
  • Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma.

  • Assess the toxicity of this regimen in this patient population.

  • Determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after documented CR. Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. Patients with stable disease receive a maximum of 4 courses.

Patients are followed at 4 weeks and then every 3 months until relapse or death.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
Actual Study Start Date :
Jan 24, 2000
Actual Primary Completion Date :
Feb 20, 2002
Actual Study Completion Date :
Sep 22, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy

    • No documented disease progression while receiving prior chemotherapy

    • CD20 and CD5 positive

    • Presence of clinically and/or radiologically documented disease

    • At least 1 site of disease must be bidimensionally measurable

    • Bone lesions not considered bidimensionally measurable

    • Minimum indicator lesions must be:

    • Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR

    • Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam

    • No known CNS involvement by lymphoma

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:
    • Absolute granulocyte count at least 1,500/mm3

    • Platelet count at least 75,000/mm3

    Hepatic:
    • Bilirubin no greater than 1.5 times upper limit or normal (ULN)

    • AST no greater than 2.5 times ULN

    Renal:
    • Creatinine no greater than 1.5 times ULN OR

    • Creatinine clearance at least 60 mL/min

    Cardiovascular:
    • No clinically significant cardiac symptomatology

    • If history of cardiac disease, cardiac ejection fraction greater than 50%

    Pulmonary:
    • No clinically significant pulmonary symptomatology

    • If history of symptomatic pulmonary disease:

    • FEV1, FVC, and TLC greater than 60% predicted

    • DLCO greater than 50% predicted

    Other:
    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • Must be accessible for treatment and follow-up (i.e., no geographical limitations)

    • No uncontrolled bacterial, fungal, or viral infection

    • No other serious concurrent disease

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No prior radioactive monoclonal antibody therapy

    • Prior rituximab allowed

    Chemotherapy:
    • See Disease Characteristics

    • No more than 2 prior chemotherapy regimens allowed

    • Same chemotherapy combination given for first line and second line therapy considered 2 regimens

    • At least 6 weeks since prior chemotherapy

    • No prior high-dose chemotherapy and stem cell transplantation

    • No other concurrent cytotoxic chemotherapy

    Endocrine therapy:
    • No concurrent corticosteroids
    Radiotherapy:
    • No prior radiotherapy to greater than 25% of functioning bone marrow

    • At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered

    • No concurrent radiotherapy to sole site of measurable disease

    Surgery:
    • At least 2 weeks since prior major surgery
    Other:
    • No other concurrent investigational anticancer agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
    2 Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario Canada L8V 5C2
    3 Toronto General Hospital Toronto Ontario Canada M5G 2C4
    4 Humber River Regional Hospital Weston Ontario Canada M9N 1N8

    Sponsors and Collaborators

    • NCIC Clinical Trials Group

    Investigators

    • Study Chair: Joseph M. Connors, MD, British Columbia Cancer Agency

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NCIC Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT00005074
    Other Study ID Numbers:
    • I127
    • CAN-NCIC-IND127
    • NCI-100
    • CDR0000067679
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Apr 9, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by NCIC Clinical Trials Group
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 9, 2020