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Biological Therapy in Treating Patients With Myelodysplastic Syndrome



Biological Therapy in Treating Patients With Myelodysplastic Syndrome

For Condition: Myelodysplastic Syndromes
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera. - Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients. - Determine the safety of this treatment regimen in this patient population. OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks. Patients are followed at 8, 16, and 20 weeks. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with: - Single or multilineage cytopenia (neutrophils less than 2,000/mm - and/or platelet count less than 100,000/mm - and/or reticulocyte count less than 18,000/mm - ) OR - Transfusion requirement of at least 2 units packed red blood cells per month and one of the following: - Suitable marrow donor unavailable - Ineligible for a transplantation protocol - Unwilling to proceed with transplantation - No chronic myelomonocytic leukemia PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Not specified Renal: - Not specified Other: - No other severe disease that would preclude study - No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior hematopoietic growth factors - No concurrent hematopoietic growth factors Chemotherapy: - At least 4 weeks since prior cytotoxic therapy - No concurrent cytotoxic therapy Endocrine therapy: - Not specified Radiation therapy: - Not specified Surgery: - Not specified Other: - At least 4 weeks since prior immunomodulatory therapy - No concurrent immunomodulatory therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
H.Deeg,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109
United States
 


Additional Information:
Study ID Numbers:  CDR0000067878;  NCI-G00-1793,FHCRC-1478.00
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005853

Other Myelodysplastic Syndromes Studies:
1. Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission

2. A Randomized Trial of Recombinant Humanized Anti-IL-2 Receptor Antibody (Daclizumab) Versus Antithymocyte Globulin (ATG) to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)

3. A study to access the safety/efficacy of thalidomide in the treatment of anemia in patients with Myelodysplastic Syndromes

4. Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

5. Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia

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