Biological Therapy in Treating Patients With Myelodysplastic Syndrome

NCT00005853 | Completed Phase 2

• 4 other identifiers: 1478.00FHCRC-1478.00NCI-G00-1793CDR0000067878
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Interventions

anti-thymocyte globulin BIOLOGICAL

etanercept BIOLOGICAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts

Interventions

Antilymphocyte Serum; Etanercept

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• H. Joachim Deeg, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: April 2, 2010

Record last verified: 2010-03

Locations

US (1)