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Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study


OBJECTIVES:

- Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with
poor risk myelodysplastic syndrome.

- Determine the hematologic response rate, cytogenetic response rate, and the rate of
polyclonal hematopoiesis following this treatment regimen.

- Determine the duration of response and time to disease progression following this
treatment regimen in these patients.

OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2
hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a
maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after
the first.

Patients are followed at least monthly for 2 years, then every 3-6 months until death.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed poor risk myelodysplastic syndrome, including at least one
of the following:

- Bilineage cytopenia

- Unfavorable cytogenetic abnormalities

- Refractory anemia with excess blasts and/or refractory anemia with excess blast
in transformation (greater than 5% blast)

- At least 0.5 on the International Prognostic Score System

- No chronic myelomonocytic leukemia

- No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%)

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count less than 1,500/mm3

- Platelet count less than 100,000/mm3

- Hemoglobin less than 10 g/dL

Hepatic:

- ALT less than 5 times upper limit of normal

Renal:

- Creatinine no greater than 1.4 mg/dL

Cardiovascular:

- No congestive heart failure

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Must have right atrial catheter inserted

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior blood or bone marrow transplantations

Chemotherapy:

- No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose
cytarabine)

- No prior topotecan

- No prior amifostine

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- At least 24 hours since prior antihypertensive medication prior to amifostine

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry C. Fung, MD, FRCPE

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066982

NCT ID:

NCT00003827

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • de novo myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000