Overview

Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Status:
Completed

Trial end date:
2000-02-01

Target enrollment:
0

Participant gender:
All

Summary

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 cyclophosphamide plus topotecan in treating patients who have refractory or relapsed acute myelogenous leukemia.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborator:

National Cancer Institute (NCI)

Treatments:

Cyclophosphamide
Topotecan

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