Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens

• Measurable or evaluable disease

• No meningeal leukemia or lymphoma

• No HIV-related lymphoma

• No lymphoproliferative diseases

PATIENT CHARACTERISTICS:

Age:

• 2 to 21

• Acute promyelocytic leukemia (APL) patients (stratum I) must be age 2 to 12

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin normal

• SGPT less than 2 times upper limit of normal

• No significant hepatic dysfunction that would preclude study therapy

Renal:

• Creatinine normal (age adjusted) OR

• Creatinine clearance at least 60 mL/min

• Potassium, magnesium, and calcium at least lower limit of normal (oral or IV supplementation allowed)

• No significant renal dysfunction that would preclude study therapy

Cardiovascular:

• Rate corrected QTc interval no greater than 0.48 on EKG

• No significant cardiac dysfunction that would preclude study therapy

• No cardiac disease, including dysrhythmias

Pulmonary:

• No significant pulmonary dysfunction that would preclude study therapy

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No persistent grade 3 or greater sensory or motor neuropathy

• No prior grand mal seizures (grade 3 or greater) within the past 2 years other than febrile seizures (except for patients with APL at discretion of investigator)

• No clinically significant unrelated systemic illness that would preclude study therapy (e.g., serious infection)

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], and epoetin alfa)

• No concurrent immunotherapy

Chemotherapy:

• No prior arsenic trioxide

• At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered

• No concurrent intrathecal chemotherapy except for acute promyelocytic leukemia (APL) patients experiencing progressive meningeal leukemia and demonstrating benefit from arsenic trioxide for systemic disease

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent steroids (except corticosteroids for retinoic acid syndrome)

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• At least 6 months since prior anticonvulsants

• At least 1 week since prior retinoid therapy

• No concurrent retinoids

• No other concurrent investigational agents