Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Keywords

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de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable atypical chronic myeloid leukemia chronic myelomonocytic leukemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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etanercept

Intervention Type BIOLOGICAL

arsenic trioxide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Bart L. Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FHCRC-1888.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000380742

Identifier Type: REGISTRY