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Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Maximum Tolerated Dose (MTD) of Amifostine

Outcome Description:

Responses are evaluated after each cycle (for a minimum of 2 induction cycles).

Outcome Time Frame:

After each 4 week cycle

Safety Issue:

No

Principal Investigator

Razelle Kurzrock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

DM97-041

NCT ID:

NCT00003048

Start Date:

May 1997

Completion Date:

February 2001

Related Keywords:

  • Myelodysplastic Syndromes
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Amifostine
  • Ethyol
  • Ethiofos
  • Gammaphos
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009