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

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Alvocidib

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