Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217386
• Other study ID #: 1872.00
• Secondary ID: FHCRC-1872.00CDR
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: September 13, 2010
• Start date: March 2004

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Biological:
• anti-thymocyte globulin

• etanercept

Locations

Country	Name	City	State
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Olympic Medical Center	Port Angeles	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses			No
Primary	Identify parameters that are associated with a high probability of response			No