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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003048 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Drug: Amifostine Trihydrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome |
| Enrollment: | 12 |
| Study Start Date: | May 1997 |
| Study Completion Date: | February 2001 |
| Primary Completion Date: | February 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Amifostine
Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)
|
Drug: Amifostine Trihydrate
Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Razelle Kurzrock, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Kurzrock, Razelle, M.D. / Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003048 History of Changes |
| Other Study ID Numbers: | DM97-041, P30CA016672, MDA-DM-97-041, ALZA-97-007-ii, ALZA-MDA-DM-97-041, NCI-V97-1300, CDR0000065687 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Federal Government |
|
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes Amifostine |
Ethyol Ethiofos Gammaphos |
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms |
Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
