A Phase I and Pharmacologic Study of UCN-01 (NSC638850)

Fecha de inicio: 1 de junio de 1998

DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is refractory to standard therapy or for which no standard therapy exists Low grade lymphoproliferative disorder defined as: Chronic lymphocytic leukemia/small lymphocytic lymphoma Waldenstrom's macroglobulinemia Follicular lymphoma (small cleaved, mixed, and large cell) Mantle cell lymphoma Prolymphocytic leukemia (T and B type) Cutaneous T cell non-Hodgkin's lymphoma Marginal zone lymphoma and variants Hairy cell leukemia variants MALT lymphomas Patients with low grade lymphoproliferative disorders must have received at least 1 or more treatment regimens and must not be eligible for potentially curative treatments (i.e., bone marrow transplantation) No HTLV-1 associated lymphomas, Burkitt's or small non-cleaved lymphomas, transplant related lymphoproliferative disorders, Hodgkin's disease, diffuse large cell lymphoma, or multiple myeloma No primary brain tumors or history of brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.2 mg/dL AST/ALT less than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of unstable or newly diagnosed angina pectoris No myocardial infarction within the last 6 months No New York Heart Association class II-IV congestive heart failure Neurologic: No grade 2 or greater peripheral neuropathy Pulmonary: No grade 2 or greater pulmonary toxicity (dyspnea on significant exertion) Other: HIV negative No autoimmune hemolytic anemia Must be able to have a central venous access catheter No active infections requiring oral or intravenous antibiotics No medical or psychiatric problems unrelated to the malignancy that may limit compliance with study, expose patient to undue risk, or confound toxicity assessment Not pregnant or nursing Adequate contraception is required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior platelet or red blood cell transfusions Chemotherapy: At least 6 weeks since nitrosoureas or mitomycin At least 4 weeks since other chemotherapy No investigational or standard chemotherapy for at least 2 months after completion of last dose of UCN-01 Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery Other: No concurrent anticonvulsant medications