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

Alternate Title

Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Any age	Other	WU-98-0185 NCI-V98-1466, NCT00008697

Objectives

1. Determine the maximum tolerated dose or minimum effective dose of arsenic trioxide in patients with refractory or recurrent acute promyelocytic leukemia.
2. Determine the efficacy of arsenic trioxide in this patient population.
3. Determine the acute and chronic toxicities of arsenic trioxide in this patient population.

Entry Criteria

Disease Characteristics:

• Pathologically confirmed acute promyelocytic leukemia (APML) (M3)



• In first or subsequent relapse following standard induction and consolidation chemotherapy (with tretinoin) and/or allogeneic bone marrow/stem cell transplant

  OR




• Failed to achieve initial complete remission with tretinoin and standard chemotherapy



• No matched sibling donor available

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent hemodialysis

Patient Characteristics:

Age:

• Any age

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• No renal failure
• Creatinine clearance at least 25 mL/min

Other:

• Not pregnant
• Fertile patients must use effective contraception

Expected Enrollment

Approximately 32 patients will be accrued for this study within 3 years.

Outline

This is a dose-escalation study.

Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period. Patients may receive up to 3 courses of treatment.

Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) or minimum effective dose (MED) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. After the MTD or MED is determined, an additional 20 patients are enrolled at this dose level.

Patients are followed monthly for 6 months and every three months for an additional 1.5 years.

Trial Contact Information

Trial Lead Organizations

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

John DiPersio, MD, PhD, Protocol chair		Ph: 314-454-8306; 800-600-3606 Email: jdipersi@im.wustl.edu

Registry Information
Official Title		A Phase I/II Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
Trial Start Date		1998-05-06
Registered in ClinicalTrials.gov		NCT00008697
Date Submitted to PDQ		1998-08-26
Information Last Verified		2004-04-30

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