Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
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| ClinicalTrials.gov Identifier: NCT00003123 |
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Recruitment Status : Unknown
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 12, 2004
Last Update Posted : November 6, 2013
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RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myelodysplastic Syndromes | Drug: amifostine trihydrate | Phase 2 |
OBJECTIVES: I. Determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome. II. Determine the toxic effects of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes three times a week. Patients failing to respond by 8 weeks undergo dose escalation. Nonresponding patients are removed from the study by 12 weeks. Therapy is continued for up to six months in responding patients. Patients are observed for duration of response upon therapy discontinuation. Patients who relapse will have therapy resumed at the previous dose. Patients will be followed until death.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes |
| Study Start Date : | August 1997 |
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| Ages Eligible for Study: | 17 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced myelodysplastic syndrome (MDS), including: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation MDS with at least bicytopenia No chronic myelomonocytic leukemia No acute leukemia
PATIENT CHARACTERISTICS: Age: 17 and over Performance Status: ECOG 0-2 Life Expectancy: Greater than 6 months Hematopoietic: Hemoglobin less than 8.5 g/dL Absolute granulocyte count less than 1,000 g/dL Platelet count less than 70,000/mm3 Hepatic: No major hepatic problems Renal: No major renal problems Cardiovascular: No major cardiac disease Other: Prior transfusion of blood products is allowed Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior cytokine therapy is allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Prior steroid therapy is allowed Radiotherapy: Not specified Surgery: Not specified Other: Prior leucovorin calcium and pyridoxine allowed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003123
| United States, Michigan | |
| Osteopathic Medical Oncology and Hematology, P.C. | |
| Clinton Township, Michigan, United States, 48038-1657 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Garden City Hospital | |
| Garden City, Michigan, United States, 48135 | |
| Marquette General Hospital | |
| Marquette, Michigan, United States, 49855 | |
| Providence Hospital Cancer Center | |
| Southfield, Michigan, United States, 48075 | |
| United States, Ohio | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Study Chair: | Howard R. Terebelo, DO | Providence Hospital |
| ClinicalTrials.gov Identifier: | NCT00003123 |
| Other Study ID Numbers: |
CDR0000065882 PH-890 ALZA-97-018-ii NCI-V97-1350 |
| First Posted: | August 12, 2004 Key Record Dates |
| Last Update Posted: | November 6, 2013 |
| Last Verified: | January 2004 |
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refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
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Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Neoplasms Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |