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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00217386

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph Cancer Center	Bellingham	Washington	United States	98225-1898
2	Olympic Medical Center	Port Angeles	Washington	United States	98362
3	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109-1023
4	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024