Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

• Status: Withdrawn
• 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.

PURPOSE: Phase I/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Harringtonines; Homoharringtonine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction

• Refractory to tretinoin, anthracyclines, and arsenic-based therapy (including arsenic trioxide) and for which no other alternative therapy of higher priority is appropriate

PATIENT CHARACTERISTICS:

Age:

• 12 and over

Performance status:

• Zubrod 0-3

Life expectancy:

• More than 4 weeks

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• ALT no greater than 3 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No active ischemia

• No other uncontrolled cardiac condition (e.g., angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure)

• No myocardial infarction within the past 12 weeks

Other:

• No other concurrent illness that would preclude study

• No other active malignancy

• No uncontrolled active infection

• No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia

• No medical or psychiatric condition that would preclude informed consent or study therapy

• HIV negative

• HTLV-I and HTLV-II negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior or concurrent leukapheresis allowed

Chemotherapy:

• See Disease Characteristics

• At least 15 days since prior systemic chemotherapy unless leukemia progression necessitates early therapy

• No other concurrent systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Recovered from prior therapy

• At least 15 days since other prior antileukemic therapy unless leukemia progression necessitates early therapy

• No other concurrent antileukemic therapy