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Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia



Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia

For Condition: recurrent childhood acute myeloid leukemia,adult acute promyelocytic leukemia (M3),childhood acute promyelocytic leukemia (M3),recurrent adult acute myeloid leukemia
Status: Recruiting
Sponsor(s): Washington University Siteman Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide in treating patients with refractory or recurrentacute promyelocytic leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose or minimum effective dose of arsenic trioxide in patients with refractory or recurrent acute promyelocytic leukemia. - Determine the efficacy of arsenic trioxide in this patient population. - Determine the acute and chronic toxicities of arsenic trioxide in this patient population. OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period. Patients may receive up to 3 courses of treatment. Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) or minimum effective dose (MED) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. After the MTD or MED is determined, an additional 20 patients are enrolled at this dose level. Patients are followed monthly for 6 months and every three months for an additional 1.5 years. PROJECTED ACCRUAL: Approximately 32 patients will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Pathologically confirmed acute promyelocytic leukemia (APML) (M3) - In first or subsequent relapse following standard induction and consolidation chemotherapy (with tretinoin) and/or allogeneic bone marrow/stem cell transplant OR - Failed to achieve initial complete remission with tretinoin and standard chemotherapy - No matched sibling donor available PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - No renal failure - Creatinine clearance at least 25 mL/min Other: - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent hemodialysis
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnDiPersio,  Study Chair,  Washington University Siteman Cancer Center

Siteman Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting John  DiPersio 314-454-8306


Additional Information:
Study ID Numbers:
  CDR0000066617;  WU-98-0185,NCI-V98-1466
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008697

Other Adult Acute Promyelocytic Leukemia (m3) Studies:
1. Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

2. Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

3. Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia

4. Bryostatin 1 and High Dose Cytarabine in Treating Patients With Refractory or Relapsed Leukemia or Lymphoma

5. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

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Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia

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