Arsenic Trioxide and Etanercept in Treating Patients With Myelodysplastic Syndromes

NCT00093366 | Completed Phase 1

• 3 other identifiers: 1888.00FHCRC-1888.00CDR0000380742
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

etanercept BIOLOGICAL

arsenic trioxide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Myeloproliferative Disorders; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Leukemia, Myelomonocytic, Chronic

Interventions

Etanercept; Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Bart L. Scott, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: June 1, 2004
• Study Completion: July 1, 2006
• Last Updated: November 30, 2011

Record last verified: 2011-11

Locations

US (1)