Factor V Leiden thrombophilia |
APC resistance, Leiden type; Hereditary resistance to activated protein C; Thrombophilia due to deficiency of cofactor for activated protein C, Leiden type |
Clinical Trial: Biological Therapy in Treating Patients With Myelodysplastic Syndrome
This study is no longer recruiting patients.
Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Myelodysplastic Syndromes | Drug: anti-thymocyte globulin Drug: tumor necrosis factor receptor IgG chimera Procedure: anti-cytokine therapy Procedure: anti-tumor necrosis factor therapy Procedure: biological response modifier therapy Procedure: non-specific immune-modulator therapy | Phase II |
MedlinePlus related topics: Bone Marrow Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Anti-Thymocyte Globulin and Tumor Necrosis Factor Receptor IgG Chimera in Patients With Myelodysplastic Syndrome
OBJECTIVES:
- Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera.
- Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients.
- Determine the safety of this treatment regimen in this patient population.
OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks.
Patients are followed at 8, 16, and 20 weeks.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:
- Single or multilineage cytopenia (neutrophils less than 2,000/mm
- and/or platelet count less than 100,000/mm
- and/or reticulocyte count less than 18,000/mm
- ) OR
- Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:
- Suitable marrow donor unavailable
- Ineligible for a transplantation protocol
- Unwilling to proceed with transplantation
- No chronic myelomonocytic leukemia
PATIENT CHARACTERISTICS: Age:
- Any age
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other severe disease that would preclude study
- No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks
PRIOR CONCURRENT THERAPY: Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior hematopoietic growth factors
- No concurrent hematopoietic growth factors
Chemotherapy:
Endocrine therapy:
- Not specified
Radiation therapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 4 weeks since prior immunomodulatory therapy
- No concurrent immunomodulatory therapy
Location Information
H. Joachim Deeg, MD, Study Chair, Fred Hutchinson Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: September 2003
Last Updated: October 13, 2004
Record first received: June 2, 2000
ClinicalTrials.gov Identifier: NCT00005853
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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