Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00005853

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes	Biological: anti-thymocyte globulin Biological: etanercept	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 1999

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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