A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Date de début de l'étude : 24 janvier 2000

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