COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Amifostine in Treating Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003048
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : October 25, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Amifostine Trihydrate Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome
Study Start Date : June 5, 1997
Actual Primary Completion Date : February 12, 2001
Actual Study Completion Date : February 12, 2001

Arm Intervention/treatment
Experimental: Amifostine
Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)
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

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Amifostine [ Time Frame: After each 4 week cycle ]
    Responses are evaluated after each cycle (for a minimum of 2 induction cycles).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003048

Layout table for location information
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Razelle Kurzrock, MD M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00003048    
Other Study ID Numbers: DM97-041
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-DM-97-041 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000065687 ( Registry Identifier: NCI PDQ )
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Keywords provided by M.D. Anderson Cancer Center:
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
Additional relevant MeSH terms:
Layout table for MeSH terms
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs