Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

NCT ID: NCT00020969

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2005-01-31

Brief 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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

arsenic trioxide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

CTI BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott C. Stromatt, MD

Role: STUDY_CHAIR

CTI BioPharma

Locations

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Green Cancer Center at Scripps Clinic

La Jolla, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Lynn Regional Cancer Center West

Boca Raton, Florida, United States

Georgia Cancer Specialists - Northside Office

Atlanta, Georgia, United States

Corpus Christi Cancer Center

Corpus Christi, Texas, United States

Countries

United States

References

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. doi: 10.1200/JCO.2005.03.7903. Epub 2006 May 1.

Reference Type: RESULT

PMID: 16651647 (View on PubMed)

Other Identifiers

CDR0000068734

Identifier Type: REGISTRY

Identifier Source: secondary_id

UCLA-HSPC-010104701

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1971

Identifier Type: -

Identifier Source: secondary_id

CTI-1058

Identifier Type: -

Identifier Source: org_study_id