ICH GCP | Clinical Trials Registry

University Health Network, Toronto 

National Cancer Institute (NCI) 

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or B-cell small lymphocytic lymphoma (SLL) - CLL is defined as: - Persistent lymphocytosis greater than 5,000/mm^3 - CD19/CD5/CD23 positive - Kappa or lambda light chain restriction - Refractory to or disease progression after 1 or 2 prior treatment regimens - Retreatment with oral chlorambucil is allowed and considered a second regimen - At least one of the chlorambucil treatments must be for 3 months or longer - At least 4 courses of cyclophosphamide, vincristine, and prednisone with or without doxorubicin allowed - Patients may have received prior fludarabine as first- or second-line therapy if there is evidence of at least partial response and time to progression after initial fludarabine therapy was at least 12 months - No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - No autoimmune hemolytic anemia or thrombocytopenia secondary to CLL or SLL requiring ongoing therapy with prednisone or other immunosuppressive agents Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - DLCO greater than 60% predicted - FEV_1 greater than 70% predicted - No significant underlying pulmonary disease Other - No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No insulin-dependent diabetes mellitus - No other uncontrolled concurrent illness - No ongoing or active infection - No pre-existing peripheral neuropathy grade 2 or greater - No psychiatric illness or social situation that would preclude study compliance - No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents in this study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy - See Hematopoietic Radiotherapy - No prior mediastinal radiation - At least 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients

All

18 Years

N/A

No

Canada

Sponsor

CDR0000256600

NCI-5538

Treatment