Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Idarubicin; Lintuzumab; Tretinoin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype

• Achieved clinical complete remission within the past 1-2 months

• Prior induction therapy must have contained tretinoin

• No other acute myeloid leukemia diagnosis

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2 mg/dL

• Transaminases no greater than 3 times upper limit of normal

Renal:

• Creatinine less than 2 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Ejection fraction normal or greater than 50% by echocardiogram or MUGA

Other:

• No other concurrent active malignancy

• No other serious or life-threatening condition that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 4 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 1 week since prior retinoids

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior postremission therapy of any form