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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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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 CenterSeattle, Washington  98109
Olympic Medical CenterPort Angeles, Washington  98362
St. Joseph Cancer CenterBellingham, Washington  98225
Seattle Cancer Care AllianceSeattle, Washington  98109