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Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia



Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

For Condition: secondary acute myeloid leukemia,recurrent adult acute myeloid leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in treating patients with relapsed acute myelogenous leukemia.
Details: OBJECTIVES: I. Determine the efficacy of a 5-day continuous infusion of carboplatin and topotecan in patients with relapsed and refractory acute myelogenous leukemia (AML). II. Assess the toxic effects of this treatment in these patients. PROTOCOL OUTLINE: Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: Up to 38 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/74 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Previously established diagnosis of acute myelogenous leukemia: Failure to achieve a complete remission with initial induction regimen; First relapse within 1 year of initial complete remission; Failure to achieve complete remission with one or two courses of reinduction therapy at first relapse; Second relapse after no more than two different induction regimens; Chemotherapy-related leukemia with unfavorable cytogenetics - No active CNS leukemia - Not eligible for allogeneic bone marrow transplant from related donor --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Recovered from the toxic effects of previous chemotherapy; At least 3 days since hydroxyurea - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: No prior or concurrent aminoglycosides or amphotericin B within past 7 days --Patient Characteristics-- - Age: 18 to 74 - Performance status: ECOG 0-2 - Life expectancy: At least 4 weeks - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than upper limit of normal (ULN) (unless elevation due to AML) - Renal: Creatinine no greater than 0.3 mg/dL above ULN - Cardiovascular: No myocardial infarction within the past 3 months; No congestive heart failure; No poorly controlled cardiac arrhythmia - Other: Not pregnant or nursing; Fertile patients must use adequate contraception; No psychosis; No active systemic infections
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelO'Connell,  Study Chair,  North Central Cancer Treatment Group


Additional Information:
Study ID Numbers:  CDR0000066143;  NCCTG-968151
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003255

Other Secondary Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes

2. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia

3. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

4. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

5. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission

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