NCT00020969

Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes.

Detailed description

OBJECTIVES: * Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide. * Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug. * Determine the durability of responses in patients treated with this drug. * Determine the duration of overall and progression-free survival of patients treated with this drug. * Assess the quality of life of patients treated with this drug. * Assess the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk). Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR. Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion. Patients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this study.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
DRUG	arsenic trioxide

Timeline

• Start date: 2001-03-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2003-01-27
• Last updated: 2020-10-05

Locations

8 sites across 1 country: United States