Trials / Completed
CompletedNCT00217386
Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | anti-thymocyte globulin | |
| BIOLOGICAL | etanercept |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2007-12-01
- First posted
- 2005-09-22
- Last updated
- 2010-09-15
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00217386. Inclusion in this directory is not an endorsement.