Biological Therapy in Treating Patients With Myelodysplastic Syndrome

March 31, 2010 updated by: Fred Hutchinson Cancer Center

Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: H. Joachim Deeg, MD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 2, 2010

Last Update Submitted That Met QC Criteria

March 31, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1478.00
  • FHCRC-1478.00
  • NCI-G00-1793
  • CDR0000067878 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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