Overview

Amifostine Plus Topotecan in Treating Patients With Myelodysplastic Syndrome

Status:
Completed

Trial end date:
2002-11-01

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. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus topotecan in treating patients with myelodysplastic syndrome.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Arizona

Treatments:

Amifostine
Topotecan

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed myelodysplatic syndrome (MDS), diagnosed
at least 3 months prior to study enrollment, with one of the following subtypes: Refractory
anemia with excess blasts (RAEB) RAEB in transformation (RAEB-T) Chronic myelomonocytic
leukemia (CMML) CMML with leukocytosis not controlled by hydroxyurea eligible in absence of
neutropenia No treatment- or mutagen-related MDS One or more cytopenias required:
Untransfused hemoglobin less than 10 g/dL and/or transfusion-dependent (requiring at least
four units of red blood cells in prior 12 weeks) Platelet count no greater than 50,000/mm3
or absolute neutrophil count less than 1,000/mm3 No myelosclerosis occupying more than 30%
of marrow

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 3 months Hematopoietic: See Disease Characteristics No hereditary
hemolytic disorders Transferrin saturation greater than 20% Ferritin at least 50 ng/mL
Hepatic: Bilirubin less than 3 mg/dL AST/ALT and LDH less than 2 times upper limit of
normal Renal: Creatinine less than 2 mg/dL Cardiovascular: No significant cardiovascular
disorders (unrelated to MDS) No uncontrolled hypertension Pulmonary: No significant
pulmonary disorders (unrelated to MDS) Neurologic: No significant neurologic disorders
(unrelated to MDS) No history of epilepsy Metabolic: No significant endocrine disorders
(unrelated to MDS) Other: Not pregnant or nursing No significant gastrointestinal diseases
(unrelated to MDS) or GI blood loss No significant genitourinary system diseases (unrelated
to MDS) No active infection requiring IV antibiotic therapy No other serious illness or
medical condition Not HIV positive Not hepatitis B surface antigen positive No iron,
vitamin B12, or folate deficiencies No autoimmune disease No prior or concurrent malignancy
within 2 years except in situ carcinoma of the cervix or basal cell or squamous cell
carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic stimulants
Chemotherapy: See Disease Characteristics At least 35 days since prior chemotherapy
Endocrine therapy: No concurrent androgen therapy No concurrent corticosteroids
Radiotherapy: Not specified Surgery: Not specified Other: At least 35 days since any
previous therapy for MDS (other than transfusion) No participation in any other
experimental clinical trial within 35 days of entry into current trial