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A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia

OBJECTIVES: I. Evaluate the efficacy of cyclophosphamide followed by topotecan in patients
with relapsed or refractory acute myelogenous leukemia. II. Confirm safety and tolerability
of this combination on this schedule in these patients.

OUTLINE: Patients receive cyclophosphamide intravenously over 1 hour on day 1 followed by
topotecan as a continuous 120 hour infusion starting 12 hours after completion of
cyclophosphamide. Treatment may be repeated every 3-6 weeks for at least 2 courses.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia by bone marrow
aspirate or biopsy Clear evidence of relapse or residual disease with greater than 5%
blasts on bone marrow examination or greater than 30% peripheral blasts No active CNS
leukemia Not eligible for potentially curative allogeneic or autologous bone marrow
transplantation without further surgery Must have failed to achieve a complete remission
with conventional chemotherapy (cytarabine based) or have relapsed within 12 months after
initial remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 6 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.6
mg/dL (unless due to disease) Renal: Creatinine less than 1.6 mg/dL (unless due to
disease) No prior hemorrhagic cystitis Other: Not pregnant Fertile patients must use
effective contraception No active uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics Recovered from prior chemotherapy No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: Must have recovered from prior radiotherapy
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Carole Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 1997

Completion Date:

Related Keywords:

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



Johns Hopkins Oncology Center Baltimore, Maryland  21287