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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00217386
First received: September 20, 2005
Last updated: September 13, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Biological: anti-thymocyte globulin
Biological: etanercept
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses [ Designated as safety issue: No ]
  • Identify parameters that are associated with a high probability of response [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2004
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept.
  • Correlate ex vivo and in vitro phenotypic, cytogenetic, and functional disease characteristics with in vivo response in patients treated with this regimen.
  • Determine parameters that are associated with a high probability of response or non-response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive anti-thymocyte globulin IV over 8 hours on days 1-4. Patients also receive etanercept subcutaneously on days 8, 11, 15, and 18. Treatment with etanercept repeats every 28 days for at least 2 courses. Patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity. Patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217386

Locations
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225-1898
Olympic Medical Center
Port Angeles, Washington, United States, 98362
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Bart L. Scott, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Bart L. Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00217386     History of Changes
Other Study ID Numbers: 1872.00, FHCRC-1872.00, CDR0000430702
Study First Received: September 20, 2005
Last Updated: September 13, 2010
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
myelodysplastic/myeloproliferative disease, unclassifiable
atypical chronic myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antilymphocyte Serum
TNFR-Fc fusion protein
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014