Suspended

Amifostine for Advanced Myelodysplastic Syndromes

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Study Aim

This study aims to evaluate the effectiveness of Amifostine as a treatment for individuals with advanced Myelodysplastic Syndromes.

What is being tested

amifostine trihydrate

Drug
Who is being recruted

Anemia+4

+ Bone Marrow Diseases

+ Hematologic Diseases

Over 17 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1997
See protocol details

Summary

Principal SponsorProvidence Hospital
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00003123
Principal SponsorProvidence Hospital
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia, RefractoryAnemia, Refractory, with Excess of BlastsMyelodysplastic Syndromes

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Osteopathic Medical Oncology and Hematology, P.C.

Clinton Township, United StatesOpen Osteopathic Medical Oncology and Hematology, P.C. in Google Maps

Barbara Ann Karmanos Cancer Institute

Detroit, United States

Henry Ford Hospital

Detroit, United States

Garden City Hospital

Garden City, United States
Suspended7 Study Centers