Clinical trial NCT00005853: Biological Therapy in Treating Patients With Myelodysplastic Syndrome
Official title: Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Myelodysplastic Syndromes
Keywords: refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
refractory cytopenia with multilineage dysplasia
childhood myelodysplastic syndromes
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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\^3 and/or platelet count less than 100,000/mm\^3 and/or reticulocyte count less than 18,000/mm\^3) 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:

* At least 4 weeks since prior cytotoxic therapy
* No concurrent cytotoxic therapy

Endocrine therapy:

* Not specified

Radiation therapy:

* Not specified

Surgery:

* Not specified

Other:

* At least 4 weeks since prior immunomodulatory therapy
* No concurrent immunomodulatory therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: H. Joachim Deeg, MD
role: STUDY_CHAIR
References: