NCT01835288

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.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

April 15, 2013

Last Update Submit

May 16, 2018

Conditions

Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Myelomonocytic Leukemia (M4)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)Recurrent Adult Acute Myeloid LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)

Outcome Measures

Primary Outcomes (1)

  • Rate of complete remission following arsenic trioxide induction

    After 4 weeks of therapy

Secondary Outcomes (1)

  • Median duration of remission

    Time from documented complete remission until time of disease relapse, assessed up to 2 years

Study Arms (1)

Treatment (arsenic trioxide)

EXPERIMENTAL

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 trioxideOther: laboratory biomarker analysis

Interventions

arsenic trioxideDRUG

Given IV

Also known as: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox
Treatment (arsenic trioxide)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (arsenic trioxide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteCongenital AbnormalitiesLeukemia, Myelomonocytic, AcuteLeukemia, Erythroblastic, Acute

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Bruno de Medeiros

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Last Updated

May 21, 2018

Record last verified: 2018-05