Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

Basic Trial Information

Objectives

1. Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide.
2. Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug.
3. Determine the durability of responses in patients treated with this drug.
4. Determine the duration of overall and progression-free survival of patients treated with this drug.
5. Assess the quality of life of patients treated with this drug.
6. Assess the toxicity profile of this drug in these patients.

Entry 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

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

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

Expected Enrollment

A total of 30-110 patients (15-55 per stratum) will be accrued for this study.

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.

Schiller GJ, Slack J, Hainsworth JD, et al.: Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol 24 (16): 2456-64, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cell Therapeutics, Incorporated

Scott Stromatt, MD, Protocol chair		Ph: 206-272-4355

Registry Information
Official Title		Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
Trial Start Date		2001-03-14
Registered in ClinicalTrials.gov		NCT00020969
Date Submitted to PDQ		2001-05-10
Information Last Verified		2004-09-03
NCI Grant/Contract Number		P30-CA16042

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