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Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00005074   Information provided by National Cancer Institute (NCI)
First Received: April 6, 2000   Last Updated: July 23, 2008   History of Changes

April 6, 2000
July 23, 2008
January 2000
 
 
 
Complete list of historical versions of study NCT00005074 on ClinicalTrials.gov Archive Site
 
 
 
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

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.

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.

Phase II
Interventional
Treatment
Lymphoma
Drug: alvocidib
 
Kouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, Lohmann R, Lopez P, Powers J, Turner R, Connors JM; National Cancer Institute of Canada Clinical Trials Group. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003 May 1;21(9):1740-5.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00005074
 
CDR0000067679, CAN-NCIC-IND127, NCI-100
NCIC Clinical Trials Group
 
Study Chair: Joseph M. Connors, MD British Columbia Cancer Agency
National Cancer Institute (NCI)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP