Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Sponsor
Stanford University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01835288
Collaborator
National Cancer Institute (NCI) (NIH)
0
1

Study Details

Study Description

Brief Summary

This phase II trial studies how well arsenic trioxide works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Detailed Description

PRIMARY OBJECTIVES:
  1. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia (AML) patients with Mutated Nucleophosmin 1 (NPM1) gene.
SECONDARY OBJECTIVES:
  1. Determine the duration of remission in these patients. II. Determine the in vivo biological effect of arsenic trioxide in AML with mutated NPM1.
OUTLINE:

Patients receive arsenic trioxide intravenously (IV) over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Arsenic Trioxide in Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Mutated Nucleophosmin 1 (NPM1) Gene
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (arsenic trioxide)

Patients receive arsenic trioxide IV over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox
  • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Rate of complete remission following arsenic trioxide induction [After 4 weeks of therapy]

    Secondary Outcome Measures

    1. Median duration of remission [Time from documented complete remission until time of disease relapse, assessed up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • AML, any French- American- British (FAB) subtype except M3, with confirmed mutation in the NPM1 gene

    • Relapsed and/or refractory AML from any duration of complete remission (CR); any number of prior therapies allowed

    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2, life expectancy > 3 months

    • Serum creatinine =< 2.0 mg/dL

    • Bilirubin =< 2.0 mg/dL

    • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)

    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:
    • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method

    • Patients who are currently receiving another investigational drug

    • Patients who are currently receiving other anti-cancer agents

    • Uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)

    • Known hypersensitivity to arsenic trioxide

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Stanford University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Bruno de Medeiros, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT01835288
    Other Study ID Numbers:
    • IRB-26938
    • NCI-2013-00767
    • HEMAML0023
    First Posted:
    Apr 18, 2013
    Last Update Posted:
    May 21, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 21, 2018