Amifostine Plus Topotecan in Treating Patients With Myelodysplastic Syndrome
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Myelodysplastic Syndromes
Intervention: amifostine trihydrate (Drug); topotecan hydrochloride (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: University of Arizona Official(s) and/or principal investigator(s):
Alan F. List, MD, Study Chair, Affiliation: University of Arizona
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.
Clinical Details
Official title: Phase I/II Study of Combined Treatment With Amifostine (Ethyol) and Topotecan (Hycamtin MS) in Patients With Myelodysplastic Syndrome
Study design: Treatment
Detailed description:
OBJECTIVES: I. Evaluate the hematologic and cytogenetic response to treatment with amifostine
plus topotecan in patients with myelodysplastic syndromes. II. Evaluate the toxic effects of
this treatment in these patients. III. Evaluate the effects of this treatment on bone marrow
recovery in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients receive amifostine IV
followed by topotecan IV over 30 minutes on days 1-5 every 4-8 weeks for at least two
courses. Patients who are responding after two courses of induction receive maintenance
courses every 6-8 weeks for up to ten courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of topotecan.
The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients
experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 26 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Arizona Cancer Center, Tucson, Arizona 85724, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 1998
Last updated: May 23, 2008
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