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Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
etanercept
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with: Single or multilineage cytopenia (neutrophils less than 2,000/mm^3 and/or platelet count less than 100,000/mm^3 and/or reticulocyte count less than 18,000/mm^3) 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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
March 31, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005853
Brief Title
Biological Therapy in Treating Patients With Myelodysplastic Syndrome
Official Title
Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Biological
Intervention Name(s)
etanercept

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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^3 and/or platelet count less than 100,000/mm^3 and/or reticulocyte count less than 18,000/mm^3) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Joachim Deeg, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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Biological Therapy in Treating Patients With Myelodysplastic Syndrome

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