Amifostine 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: Myelodysplastic Syndromes
Intervention: amifostine trihydrate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Razelle Kurzrock, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Summary
RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with
myelodysplastic syndrome.
Clinical Details
Official title: Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome
Study design: Supportive Care
Detailed description:
OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with
myelodysplastic syndrome.
OUTLINE: This is an open label, nonrandomized, single center, dose escalation study. Patients
receive amifostine IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4
weeks. Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
Patients with a grade 0 toxicity in the first course receive a 25% increase in dose during
the second course. Patients with grade 1 or 2 toxicity receive no dose change. Patients with
grade 3 toxicity receive a 25% reduction in dose or treatment is stopped. All patients
demonstrating response are eligible for maintenance therapy. Treatment is continued for up to
12 months or a total of 13 cycles.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Less than 30%
blasts in bone marrow
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Zubrod 0-2 Karnofsky 60-100%
ECOG 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal:
Creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart Association Class IV
disease No antihypertensive medication within 24 hours of amifostine administration Other:
Not pregnant or nursing Effective contraceptive method must be used during study No medical
illness No psychosis Eligible patients with an HLA compatible donor are referred to bone
marrow transplantation
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy within 4 weeks of study and recovered Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified
Locations and Contacts
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1997
Last updated: May 23, 2008
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