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

NCT ID: NCT00005074

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-24
• Study Completion Date: 2008-09-22

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alvocidib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph M. Connors, MD

Role: STUDY_CHAIR

British Columbia Cancer Agency

Locations

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Humber River Regional Hospital

Weston, Ontario, Canada

Countries

Canada

References

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. doi: 10.1200/JCO.2003.09.057.

Reference Type: RESULT

PMID: 12735303 (View on PubMed)

Other Identifiers

CAN-NCIC-IND127

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-100

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067679

Identifier Type: OTHER

Identifier Source: secondary_id

I127

Identifier Type: -

Identifier Source: org_study_id