Lymphoma
Conditions
Keywords
recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma
Brief summary
Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES: I. Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkin's lymphoma and mantle cell lymphoma. II. Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients. III. Study the pharmacokinetics of flavopiridol in these patients. OUTLINE: This is an open label, multi-institutional study. Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs. Patients are followed until death.
Interventions
DRUGalvocidib
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma with clinical or pathological evidence of recurrent disease * Measurable or evaluable disease * CNS metastases not requiring intravenous steroid therapy allowed PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: CALGB 0-2 * Life expectancy: At least 12 weeks * Absolute neutrophil count at least 1500/mm3 (unless due to bone marrow involvement by lymphoma) * Platelet count at least 100,000/mm3 (unless due to bone marrow involvement by lymphoma) * At least 7 days since platelet transfusion * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal * Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min * No significant uncontrolled medical or psychiatric illness * No active serious infection * Not pregnant or lactating * Fertile patients must use effective contraception * Central venous catheter required prior to study entry PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy regimen * At least 4 weeks since prior chemotherapy and recovered from all toxic effects Prior chemotherapy must contain anthracycline if intermediate or high-grade NHL other than mantle cell * No concurrent treatment with other chemotherapeutic or investigational antineoplastic drugs * At least 4 weeks since prior radiation therapy and recovered (Site of only measurable disease must not be located within prior radiation therapy port) * No concurrent radiation therapy to any lesion
Countries
United States
Outcome results
None listed