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Home > "H" Clinical Trials Conditions > Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia  Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
For Condition: recurrent adult acute myeloid leukemia,childhood acute promyelocytic leukemia (M3),adult acute promyelocytic leukemia (M3),recurrent childhood acute myeloid leukemia
Status: Recruiting
Sponsor(s): ChemGenex Therapeutics ,
Synopsis: 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 refractoryacutepromyelocytic leukemia.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JorgeCortes, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Jorge Cortes 713-794-5783
Additional Information:
Study ID Numbers: CDR0000069158; CHEMGENEX-CGX-635-APL-101,MDA-DM-01265
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030355
Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
2. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
3. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
4. Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
Related Studies:
Other recurrent adult acute myeloid leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
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