Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

NCT00003123 | Unknown Phase 2

• 4 other identifiers: CDR0000065882PH-890ALZA-97-018-iiNCI-V97-1350
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Myelodysplastic Syndromes

Keywords

refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation

Interventions

amifostine trihydrate DRUG

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Providence Hospital: lead

Study Sites (7)

Osteopathic Medical Oncology and Hematology, P.C.

Clinton Township, Michigan, 48038-1657, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Garden City Hospital

Garden City, Michigan, 48135, United States

Location

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

Providence Hospital Cancer Center

Southfield, Michigan, 48075, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Terebelo H, Marsico D, Shurafa M, et al.: A phase II trial of amifostine in patients with advanced myelodysplastic syndromes. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A82, 23a, 1999.

  RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Howard R. Terebelo, DO

  Providence Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 12, 2004
• Study Start: August 1, 1997
• Last Updated: November 6, 2013

Record last verified: 2004-01

Locations

US (7)