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Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)

Phase 2
18 Years
74 Years
Not Enrolling

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Trial Information

Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)

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.

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.

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott H. Kaufmann, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid