Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

NCT00217386 | Completed Phase 2

• 3 other identifiers: 1872.00FHCRC-1872.00CDR0000430702
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

Keywords

de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; myelodysplastic/myeloproliferative disease, unclassifiable; atypical chronic myeloid leukemia

Outcome Measures

Primary Outcomes (3)

• Response rate

• Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses

• Identify parameters that are associated with a high probability of response

Interventions

anti-thymocyte globulin BIOLOGICAL

etanercept BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of myelodysplastic syndromes (MDS) * Low- or intermediate-1-risk disease, as defined by International Prognostic Scoring System (IPSS) criteria, meeting 1 of the following criteria: * Single or multilineage cytopenia, as defined by all of the following: * Absolute neutrophil count \< 1,500/mm\^3 * Hemoglobin \< 10 g/dL * Platelet count \< 100,000/mm\^3 * Transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period * Not eligible for stem cell transplantation due to any of the following reasons: * No suitable bone marrow donor available * Not eligible for a transplantation protocol * Not willing to undergo transplantation * No intermediate-2- or high-risk MDS * No chronic myelomonocytic leukemia PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Pulmonary * No pneumonia within the past 2 weeks Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other severe disease that would preclude study compliance * No other active severe infection (e.g., septicemia) within the past 2 weeks PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS * More than 4 weeks since prior immunomodulatory therapy for MDS * No prior anti-thymocyte globulin * No prior hematopoietic stem cell transplantation * No other concurrent immunomodulatory therapy for MDS Chemotherapy * Not specified Endocrine therapy * Prednisone \< 5 mg/day allowed Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS * More than 4 weeks since prior experimental therapy for MDS * No other concurrent experimental therapy for MDS

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 (4)

St. Joseph Cancer Center

Bellingham, Washington, 98225-1898, United States

Location

Olympic Medical Center

Port Angeles, Washington, 98362, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Myeloproliferative Disorders; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Antilymphocyte Serum; Etanercept

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Bart L. Scott, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2004
• Primary Completion: December 1, 2007
• Last Updated: September 15, 2010

Record last verified: 2010-09

Locations

US (4)