Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT00093366
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00093366
Study Brief:
Protocol Section:
NCT00093366