RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients
who have advanced hematologic cancer.
OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide
suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine
the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate
evidence of clinical responsiveness that may provide leads for further testing in patients
treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4
hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at
which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed
for 1 month.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven hematologic cancer, including acute or
chronic leukemia, malignant lymphoma, or multiple myeloma Exclude acute promyelocytic
leukemia (M3) Relapse from or resistance to at least one course of standard anticancer
therapy and lack of alternative therapy that has proven to be curative in the underlying
PATIENT CHARACTERISTICS: Age: 17 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL
Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Fertile
patients must use effective contraception during and for at least 4 months after study No
history of grand mal seizures (other than infantile febrile seizures) No active serious
infections that are not controlled by antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent
cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent
radiotherapy Surgery: Not specified Other: No other concurrent investigational agents