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

Phase 2

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

• Registration Number: NCT00217386
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2007-12
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-13
• Last Update Posted: 2010-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Olympic Medical Center; 🇺🇸 Port Angeles, Washington, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

St. Joseph Cancer Center; 🇺🇸 Bellingham, Washington, United States