homoharringtonine in treating patients with refractory acute promyelocytic leukemia

Conditions: Leukemia

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.

objectives: * determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia. * determine the antileukemic efficacy of this drug in these patients. outline: patients receive remission induction therapy comprising homoharringtonine (hh) iv continuously on days 1-14. courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission (cr) is achieved or the patient fails to respond after 3 courses. patients who achieve a cr during induction therapy receive maintenance therapy comprising hh iv continuously on days 1-7. maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks. projected accrual: a maximum of 20 patients will be accrued for this study.

Eligibility 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

Keywords: recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia adult acute promyelocytic leukemia (m3) childhood acute promyelocytic leukemia (m3) adult acute myeloid leukemia with t(15;17)(q22;q12)