search
Back to results

Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

Primary Purpose

de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
azacitidine
etanercept
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for de Novo Myelodysplastic Syndromes

Eligibility Criteria

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

Inclusion Criteria: Int-2 or high risk MDS patients Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with: Single or multilineage cytopenia (absolute neutrophil count [ANC] < 1500/μL, hemoglobin [Hgb],10g/dL, or platelet count < 100,000/μL); or Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period Serum creatinine =< 1.5x ULN (upper limit of normal) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2x ULN Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale, 0-5) Exclusion Criteria: Patients who have previously received hematopoietic stem cell transplants, specifically for MDS Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e >= 20% blasts) at time of enrollment Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study Men who are unwilling to use contraception while receiving 5-aza Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure Platelet count =< 10,000/mcl Absolute neutrophil count =< 250/mcl Prior treatment with 5-aza Known or suspected hypersensitivity to azacitidine or mannitol

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (chemotherapy, chemoprotection)

Arm Description

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2005
Last Updated
April 17, 2017
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00118287
Brief Title
Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
Official Title
Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy
Detailed Description
PRIMARY OBJECTIVES: I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept. II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and for the purpose of this trial are considered as having progressive or "more advanced" disease. III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional disease characteristics with in vivo treatment responses, to identify parameters that are associated with a high probability of response. OUTLINE: Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (chemotherapy, chemoprotection)
Arm Type
Experimental
Arm Description
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
azacitidine
Other Intervention Name(s)
5-AC, 5-azacytidine, azacytidine, Vidaza
Intervention Description
Given SC or IV
Intervention Type
Biological
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel, ETN, TNFR:Fc, Tumor Necrosis Factor Receptor IgG Chimera
Intervention Description
Given SC
Primary Outcome Measure Information:
Title
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Description
Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Int-2 or high risk MDS patients Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with: Single or multilineage cytopenia (absolute neutrophil count [ANC] < 1500/μL, hemoglobin [Hgb],10g/dL, or platelet count < 100,000/μL); or Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period Serum creatinine =< 1.5x ULN (upper limit of normal) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2x ULN Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale, 0-5) Exclusion Criteria: Patients who have previously received hematopoietic stem cell transplants, specifically for MDS Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e >= 20% blasts) at time of enrollment Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study Men who are unwilling to use contraception while receiving 5-aza Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure Platelet count =< 10,000/mcl Absolute neutrophil count =< 250/mcl Prior treatment with 5-aza Known or suspected hypersensitivity to azacitidine or mannitol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Scott
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

We'll reach out to this number within 24 hrs