Biological Therapy in Treating Patients With Myelodysplastic Syndrome - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00005853

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	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Biological: anti-thymocyte globulin Biological: etanercept	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date:	December 1999
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005853

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

H. Joachim Deeg, MD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067878, FHCRC-1478.00, NCI-G00-1793
Study First Received:	June 2, 2000
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00005853 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
TNFR-Fc fusion protein
Leukemia
Preleukemia
Pathologic Processes
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Disease

Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Antilymphocyte Serum
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Bone Marrow Diseases
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009