Phase I and Clinical Pharmacokinetic De-Escalation Study of 2'-Deoxycitidine Administered as a Continuous Infusion in Conjunction With a Continuous Infusion of High-Dose ARA-C in Patients With Refractory Acute Myelogenous Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS: One of the following histologically documented hematologic
malignancies: Acute myelogenous leukemia Failed or relapsed following conventional dose
chemotherapy (e.g., doxorubicin, cytarabine) or high dose cytarabine (HD ARA-C) Chronic
myelogenous leukemia in blast crisis that has failed at least 1 conventional antileukemic
regimen Acute lymphoblastic leukemia (ALL) that is relapsed following or initially
refractory to conventional therapy Failed at least 1 salvage regimen for ALL Disease
refractory to conventional HD ARA-C allowed Primarily refractory or relapsed Hodgkin's or
non-Hodgkin's lymphoma Failed at least 1 conventional second or third generation regimen
(e.g., ProMACE-CytaBOM) Refractory multiple myeloma Not eligible for protocols of higher
priority and no alternative forms of therapy available that offer a reasonable chance of
palliation or cure

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life
expectancy: At least 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 3
mg/dL Renal: Creatinine clearance at least 40 mL/min Pulmonary: Pulse oximetry greater
than 88% in patients with a history of pulmonary disease Other: No major concurrent
disease that renders patient a poor medical risk No uncontrolled infection Disease related
fever allowed at investigator's discretion No mental incapacity that precludes informed
consent No incarcerated patients Not pregnant Effective contraception required of fertile
women

PRIOR CONCURRENT THERAPY: Not specified Biologic therapy: Not specified Chemotherapy: At
least 3 weeks since prior chemotherapy (24 hours since hydroxyurea) and recovered
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 30% or more of
bone marrow At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified