Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
OBJECTIVES:
-
Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Pharmacokinetics []
- Duration of treatment response []
- Survival []
- Induction mortality []
- Hospitalizations []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction
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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
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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:
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No other concurrent illness that would preclude study
-
No other active malignancy
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No uncontrolled active infection
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No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia
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No medical or psychiatric condition that would preclude informed consent or study therapy
-
HIV negative
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HTLV-I and HTLV-II negative
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | M. D. Anderson Cancer Center at University of Texas | Houston | Texas | United States | 77030-4009 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Study Chair: Jorge Cortes, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000069158
- CHEMGENEX-CGX-635-APL-101
- MDA-DM-01265