Biological Therapy in Treating Patients With Myelodysplastic Syndrome

Leukemia Clinical Trial

Official title:

Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005853
• Other study ID #: 1478.00
• Secondary ID: FHCRC-1478.00NCI
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: March 31, 2010
• Start date: December 1999
• Est. completion date: August 2005

Study information

• Verified date: March 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Biological:
• anti-thymocyte globulin

• etanercept

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,