Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
18 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Trial Information
Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Bart L. Scott, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1872.00
NCT ID:
NCT00217386
Start Date:
March 2004
Completion Date:
Related Keywords:
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- myelodysplastic/myeloproliferative disease, unclassifiable
- atypical chronic myeloid leukemia
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Olympic Medical Center | Port Angeles, Washington 98362 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
