Clinical Trial: Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome

This study is no longer recruiting patients.

Sponsored by: Providence Hospital Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
Refractory Anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
 Drug: amifostine
Phase II

MedlinePlus related topics:  Anemia;   Bone Marrow Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Amifostine (Ethyol) in Patients with Advanced Myelodysplastic Syndrome

Further Study Details: 

Study start: August 1997

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  17 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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

Location Information


Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States

      Garden City Hospital, Garden City,  Michigan,  48135,  United States

      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States

      Marquette General Hospital, Marquette,  Michigan,  49855,  United States

      Osteopathic Medical Oncology and Hematology, P.C., Clinton Township,  Michigan,  48038-1657,  United States

      Providence Hospital Cancer Center, Southfield,  Michigan,  48075,  United States

Ohio
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States

Study chairs or principal investigators

Howard R. Terebelo,  Study Chair,  Providence Hospital Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065882; PH-890; NCI-V97-1350; ALZA-97-018-ii
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003123
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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