Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00020969
• Other study ID #: CTI-1058
• Secondary ID: CDR0000068734UCL
• Status: Terminated
• Phase: Phase 2
• Start date: March 2001
• Est. completion date: January 2005

Study information

• Verified date: October 2020
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	Georgia Cancer Specialists - Northside Office	Atlanta	Georgia
United States	Lynn Regional Cancer Center West	Boca Raton	Florida
United States	Corpus Christi Cancer Center	Corpus Christi	Texas
United States	Green Cancer Center at Scripps Clinic	La Jolla	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
CTI BioPharma	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schiller GJ, Slack J, Hainsworth JD, Mason J, Saleh M, Rizzieri D, Douer D, List AF. Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol. 2006 Jun 1;24(16):2456-64. Epub 2006 May 1. — View Citation