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

• Response rate [ Designated as safety issue: No ]
• Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses [ Designated as safety issue: No ]
• Identify parameters that are associated with a high probability of response [ Designated as safety issue: No ]

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.

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.

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

• Biological: anti-thymocyte globulin
• Biological: etanercept

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