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Azacitidine Plus Amifostine in Treating Patients With Myelodysplastic Syndrome
This study has been completed.
First Received: May 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Michigan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005598
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Amifostine may improve blood counts in patients with myelodysplastic syndrome. Combining azacitidine with amifostine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of azacitidine plus amifostine in treating patients who have myelodysplastic syndrome.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: amifostine trihydrate
Drug: azacitidine
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Amifostine Azacitidine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of 5-Azacytidine (NSC #102816) and Ethyol (Amifostine) in the Treatment of Adults With Myelodysplastic Syndromes

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

Study Start Date: October 2000
Detailed Description:

OBJECTIVES: I. Determine the response rate to azacitidine plus amifostine in patients with myelodysplastic syndromes. II. Evaluate the toxicity of this treatment regimen in these patients. III. Assess the rate of progression to acute myeloid leukemia and overall survival in these patients treated with this regimen. IV. Evaluate the relationship between response status and cytogenetics, FAB class, ras mutations, and the presence of nonclonal hematopoiesis with this treatment regimen in these patients. V. Assess the effect of this treatment regimen on the number of bone marrow hematopoietic progenitor cells in these patients. VI. Evaluate neutrophil adhesion and chemotaxis in these patients before and after this treatment regimen.

OUTLINE: Patients receive amifostine IV over 1-3 minutes on days 8, 10, 12, 15, 17, 19, 22, 24, and 26 plus azacitidine subcutaneously on days 1-7.

Treatment repeats every 28 days for 4 courses. Patients who achieve complete remission receive an additional 3 courses, and patients who achieve hematologic improvement or partial remission continue treatment until disease progression or unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within approximately 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS) Intermediate 1, 2, or high risk disease OR Low risk disease with one of the following: Symptomatic anemia requiring transfusion for at least 3 months prior to study Symptomatic thrombocytopenia requiring platelet transfusion Platelet count less than 50,000/mm3 Absolute neutrophil count less than 1,000/mm3 with an infection Stable disease for 1 month with no progression to acute myeloid leukemia Declined or not eligible for allogeneic bone marrow transplant (alloBMT) No prior treatment of MDS with chemotherapy or alloBMT No prior leukemia or more than 30% myeloblasts in the bone marrow

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: 0-2 Life expectancy: Greater than 4 months Hematopoietic: See Disease Characteristics

Hepatic: Bilirubin less than 1.5 times normal (unless due to hemolysis or ineffective erythropoiesis) AST and ALT less than 2 times normal Renal:

Creatinine less than 1.5 times normal Cardiovascular: No uncontrolled or severe congestive heart failure Pulmonary: Serum CO2 greater than 18 mmHg Other: No uncorrected folate or vitamin B12 deficiency HIV negative No other medical or psychiatric illness that would preclude study At least 3 years since prior nonleukemic malignancy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior interferon, interleukin-3, or interleukin-11 At least 1 month since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent hematologic growth factors Chemotherapy: See Disease Characteristics Prior chemotherapy for nonleukemic malignancy allowed No prior azacitidine Endocrine therapy: At least 1 month since prior corticosteroids or danazol No concurrent steroids Radiotherapy: Prior radiotherapy for nonleukemic malignancy allowed Surgery: Not specified Other: No prior antithymocyte globulin or cyclosporine No prior amifostine

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005598

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Study Chair: Harry P. Erba, MD, PhD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067711, CCUM-9906, NCI-T99-0069
Study First Received: May 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005598     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Antimetabolites
Radiation-Protective Agents
Precancerous Conditions
Amifostine
Hematologic Diseases
Myelodysplastic Syndromes
Anemia
Refractory Anemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Azacitidine
Bone Marrow Diseases

Additional relevant MeSH terms:
Antimetabolites
Radiation-Protective Agents
Disease
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Amifostine
Antineoplastic Agents
Hematologic Diseases
Physiological Effects of Drugs
Myelodysplastic Syndromes
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Azacitidine
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009