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Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
etanercept
arsenic trioxide
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, chronic myelomonocytic leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of myelodysplastic syndromes (MDS) meeting 1 of the following criteria: Intermediate-2 or high-risk disease Intermediate-1 or low-risk disease that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872 Not eligible for stem cell transplantation for any of the following reasons: Suitable bone marrow donor is not available Ineligible for a transplantation protocol Not willing to undergo transplantation PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 500/mm^3 Hepatic Not specified Renal Not specified Cardiovascular No evidence of cardiac arrhythmia No evidence of congestive heart failure QTc interval ≤ 460 msec Pulmonary No pneumonia Other Potassium > 4.0 mEq/L (supplemental electrolytes allowed) Magnesium > 1.8 mg/dL (supplemental electrolytes allowed) No history of anaphylactic reaction to arsenic trioxide No active severe infection (e.g., septicemia) within the past 2 weeks No other severe disease that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior hematopoietic stem cell transplantation More than 4 weeks since prior hematopoietic growth factors for MDS More than 4 weeks since prior immunomodulatory therapy for MDS No concurrent hematopoietic growth factors for MDS No other concurrent immunomodulatory therapy for MDS Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 4 weeks since prior cytotoxic therapy for MDS More than 4 weeks since prior experimental therapy for MDS No other concurrent cytotoxic therapy for MDS No other concurrent experimental therapy for MDS

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes
Efficacy of this regimen in patients with intermediate-1 or low-risk MDS that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872
Correlate results of ex vivo and in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
Parameters that are associated with a high probability of response

Secondary Outcome Measures

Full Information

First Posted
October 6, 2004
Last Updated
November 28, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00093366
Brief Title
Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes
Official Title
Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as etanercept may interfere with the growth of the cancer cells. Combining chemotherapy with biological therapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide together with etanercept and to see how well it works in treating patients with myelodysplastic syndromes.
Detailed Description
OBJECTIVES: Determine the frequency of hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) treated with arsenic trioxide and etanercept. Determine the efficacy of this regimen in patients with intermediate-1 or low-risk MDS that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872. Correlate results of ex vivo and in vitro studies of phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment response in patients treated with this regimen. Determine parameters that are associated with a high probability of disease response in patients treated with this regimen. OUTLINE: This is a pilot study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 of week 1 and then twice weekly on weeks 2-12 during course 1 (twice weekly on weeks 1-12 during course 2). Patients also receive etanercept subcutaneously twice weekly during weeks 1, 2, 5, 6, 9, and 10. Treatment repeats every 12 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 15-32 patients will be accrued for this study within 8-18 months.

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, chronic myelomonocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
etanercept
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Primary Outcome Measure Information:
Title
Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes
Title
Efficacy of this regimen in patients with intermediate-1 or low-risk MDS that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872
Title
Correlate results of ex vivo and in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses
Title
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) meeting 1 of the following criteria: Intermediate-2 or high-risk disease Intermediate-1 or low-risk disease that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872 Not eligible for stem cell transplantation for any of the following reasons: Suitable bone marrow donor is not available Ineligible for a transplantation protocol Not willing to undergo transplantation PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 500/mm^3 Hepatic Not specified Renal Not specified Cardiovascular No evidence of cardiac arrhythmia No evidence of congestive heart failure QTc interval ≤ 460 msec Pulmonary No pneumonia Other Potassium > 4.0 mEq/L (supplemental electrolytes allowed) Magnesium > 1.8 mg/dL (supplemental electrolytes allowed) No history of anaphylactic reaction to arsenic trioxide No active severe infection (e.g., septicemia) within the past 2 weeks No other severe disease that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior hematopoietic stem cell transplantation More than 4 weeks since prior hematopoietic growth factors for MDS More than 4 weeks since prior immunomodulatory therapy for MDS No concurrent hematopoietic growth factors for MDS No other concurrent immunomodulatory therapy for MDS Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 4 weeks since prior cytotoxic therapy for MDS More than 4 weeks since prior experimental therapy for MDS No other concurrent cytotoxic 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
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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Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes

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