Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00030355


Primary Contact:

Study Chair
Jorge Cortes, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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