Overview

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of topotecan and etoposide in treating patients who have recurrent or refractory leukemia.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Etoposide
Etoposide phosphate
Topotecan
Criteria
DISEASE CHARACTERISTICS: Acute myelogenous leukemia (M0-M7) and acute lymphoblastic
leukemia (L1-L2) Refractory or in first or subsequent relapse Circulating blasts present OR
Greater than 5% blasts in bone marrow Acute myelogenous leukemia secondary to
myelodysplastic syndrome or cytotoxic therapy Untreated OR Maximum of 2 intensive induction
regimens Chronic myelogenous leukemia in blastic or lymphoid crisis Untreated OR Maximum of
2 intensive induction regimens No CNS leukemia

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-3 Life expectancy: At
least 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL AST
and ALT less than 3 times normal Alkaline phosphatase less than 3 times normal Renal:
Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min
Cardiovascular: No myocardial infarction within 6 months No active ischemic cardiac disease
No poorly controlled congestive heart failure No other symptomatic cardiac disease Left
ventricular ejection fraction at least 40% Pulmonary: No symptomatic restrictive or
obstructive lung disease Other: No severe neurologic disease No active infection unless
stable on antimicrobial therapy or fever is tumor related HIV negative Not pregnant or
nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: At least 2 weeks since prior cytotoxic therapy (except
hydroxyurea and steroids) Biologic therapy: No prior bone marrow transplantation At least 3
days since prior hematopoietic growth factors Chemotherapy: No prior topotecan or
camptothecin analogues Prior etoposide allowed Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified