Leukemia
Conditions
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)
Brief 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.
Detailed description
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.
Interventions
PROCEDUREchemotherapy
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events | — |
| Efficacy by response to treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival | — |
| Pharmacokinetics | — |
| Hospitalizations | — |
| Induction mortality | — |
| Duration of treatment response | — |
Countries
United States
Outcome results
None listed