This trial is active, not recruiting.

Conditions leukemia, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms
Treatment arsenic trioxide
Phase phase 2
Sponsor CTI BioPharma
Collaborator National Cancer Institute (NCI)
Start date March 2001
Trial identifier NCT00020969, CDR0000068734, CTI-1058, NCI-G01-1971, UCLA-HSPC-010104701


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of myelodysplastic syndromes (MDS) - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - Low-risk MDS patients: - If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial - No prior acute myeloid leukemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - More than 3 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - SGPT and SGOT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients) Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - At least 30 days since prior radiotherapy Surgery: - Not specified Other: - At least 30 days since prior cytotoxic agents - At least 30 days since prior investigational agents - No prior arsenic trioxide

Additional Information

Official title Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).