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

Tracking Information

First Received Date ^ICMJE

January 13, 2001

Last Updated Date

July 23, 2008

Start Date ^ICMJE

May 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00008697 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I/II Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide in treating patients with refractory or recurrent acute promyelocytic leukemia.

Detailed Description

OBJECTIVES:

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

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.

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

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Drug: arsenic trioxide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

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

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00008697

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066617, WU-98-0185, NCI-V98-1466

Study Sponsor ^ICMJE

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

John F. DiPersio, MD, PhD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP