Clinical Trials /

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

NCT01835288

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
  • 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

Clinical Trial IDs

  • ORG STUDY ID: IRB-26938
  • SECONDARY ID: NCI-2013-00767
  • SECONDARY ID: HEMAML0023
  • NCT ID: NCT01835288

Conditions

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • 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) Abnormalities
  • Adult 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 Leukemia

Interventions

DrugSynonymsArms
arsenic trioxideArsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, TrisenoxTreatment (arsenic trioxide)

Purpose

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:

      I. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia
      (AML) patients with Mutated Nucleophosmin 1 (NPM1) gene.

      SECONDARY OBJECTIVES:

      I. 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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (arsenic trioxide)ExperimentalPatients 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.
  • arsenic trioxide

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of complete remission following arsenic trioxide induction
Time Frame:After 4 weeks of therapy
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Median duration of remission
Time Frame:Time from documented complete remission until time of disease relapse, assessed up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Withdrawn
Lead Sponsor:Stanford University

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