NCT00008697

Brief Summary

The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic trioxide in the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APML). In addition, correlation between pharmacokinetic data and both therapeutic response and therapy-related toxicities will be sought.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Nov 1998

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

3.4 years

First QC Date

January 13, 2001

Last Update Submit

April 11, 2013

Conditions

Leukemia

Keywords

recurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiaadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) or minimum effective dose (MED)

    6 weeks

  • Efficacy (response and survival) at the MTD - Phase 2 only

    18 weeks

Secondary Outcomes (3)

  • Acute and chronic toxicities

    18 weeks

  • Evaluation of the pharmacokinetics and their correlation with toxicities and response

    18 weeks

  • Evaluation of PML/RARA and PML protein redistribution and degradation following treatment and their correlation with response

    18 weeks

Study Arms (2)

Phase 1

EXPERIMENTAL

Cohort 1 Arsenic trioxide = 0.1 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks) Cohort 2 Arsenic trioxide = 0.15 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks) Cohort 3 Arsenic trioxide = 0.20 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks) Cohort 4 Arsenic trioxide = 0.25 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks) Cohort 5 Arsenic trioxide = 0.30 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)

Drug: arsenic trioxide

Phase 2

EXPERIMENTAL

Arsenic trioxide = MTD found in Phase 1 mg/kg/day x 28 days with 14 day rest for 3 cycles (each cycle = 6 weeks)

Drug: arsenic trioxide

Interventions

arsenic trioxideDRUG
Phase 1Phase 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • APML diagnosis based upon morphological, histochemical, and/or flow cytometric criteria, confirmed upon review by a central, study-designated hematologic pathologist;
  • any relapsed acute leukemia bearing a t(15:17) translocation or variant APML translocations involving the retinoic acid receptor alpha gene on chromosome 15q22, based on cytogenetics or PCR.
  • disease in first or subsequent relapse, following standard induction and consolidation chemotherapy (with all-trans retinoic acid) and/or allogeneic bone marrow/stem cell transplantation;
  • failure to achieve initial complete remission with ATRA and standard chemotherapy.

You may not qualify if:

  • Availability of a fully HLA-matched sibling donor for patients otherwise felt to be candidates for allogeneic bone marrow/stem cell transplantation; patients with only a partially HLA-matched sibling or matched unrelated donor will remain eligible for study entry.
  • pregnancy.
  • Patients with significantly impaired left ventricular ejection fraction (\<40%) will be ineligible for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Promyelocytic, Acute

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • John F. DiPersio, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2001

First Posted

January 27, 2003

Study Start

November 1, 1998

Primary Completion

April 1, 2002

Study Completion

April 1, 2002

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

US(1)