ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Amifostine in Treating Patients With Myelodysplastic Syndrome

This study is ongoing, but not recruiting participants.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003048
  Purpose

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 Intervention Phase
Myelodysplastic Syndromes
Drug: amifostine trihydrate
Phase II

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Amifostine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   Phase II Study of Intravenous Amifostine in Myelodysplastic Syndrome

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   May 1997

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003048

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Study Chair:     Razelle Kurzrock, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065687, MDA-DM-97-041, ALZA-97-007-ii, ALZA-MDA-DM-97-041, NCI-V97-1300
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003048
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
de novo myelodysplastic syndromes  
previously treated myelodysplastic syndromes  
secondary myelodysplastic syndromes  

Study placed in the following topic categories:
Myelodysplastic syndromes
Preleukemia
Amifostine
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Neoplasm Metastasis
Bone Marrow Diseases

Additional relevant MeSH terms:
Radiation-Protective Agents
Neoplasms
Pathologic Processes
Disease
Syndrome
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers