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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00005074
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:

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
Lymphoma Drug: alvocidib 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
Study Start Date : January 2000
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005074


Locations
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
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
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005074     History of Changes
Other Study ID Numbers: I127
CAN-NCIC-IND127
NCI-100
CDR0000067679 ( Other Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
stage II mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Alvocidib
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action