Leukemia, Myelodysplastic/Myeloproliferative Diseases, Myelodysplastic Syndromes
Conditions
Keywords
de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, unclassifiable, atypical chronic myeloid leukemia
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.
Interventions
BIOLOGICALanti-thymocyte globulin
BIOLOGICALetanercept
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed