Amifostine in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00003048
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012

November 1, 1999
July 27, 2012
May 1997
February 2001   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) of Amifostine [ Time Frame: After each 4 week cycle ] [ Designated as safety issue: No ]
Responses are evaluated after each cycle (for a minimum of 2 induction cycles).
Not Provided
Complete list of historical versions of study NCT00003048 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Amifostine in Treating Patients With Myelodysplastic Syndrome
Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome

RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Myelodysplastic Syndromes
Drug: Amifostine Trihydrate
Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.
Other Names:
  • Ethyol
  • Ethiofos
  • Gammaphos
Experimental: Amifostine
Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)
Intervention: Drug: Amifostine Trihydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2001
February 2001   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003048
DM97-041, P30CA016672, MDA-DM-97-041, ALZA-97-007-ii, ALZA-MDA-DM-97-041, NCI-V97-1300, CDR0000065687
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Razelle Kurzrock, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP