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

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
etanercept
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, unclassifiable, atypical chronic myeloid leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph Cancer Center
  • Olympic Medical Center
  • Seattle Cancer Care Alliance
  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Response rate
Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
Identify parameters that are associated with a high probability of response

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
September 13, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217386
Brief Title
Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
Official Title
Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Keywords
de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, unclassifiable, atypical chronic myeloid leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Biological
Intervention Name(s)
etanercept
Primary Outcome Measure Information:
Title
Response rate
Title
Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
Title
Identify parameters that are associated with a high probability of response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart L. Scott, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225-1898
Country
United States
Facility Name
Olympic Medical Center
City
Port Angeles
State/Province
Washington
ZIP/Postal Code
98362
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

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

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