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

Related Clinical Trial
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia Tipifarnib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy Bortezomib, Mitoxantrone, Etoposide, and Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML Trebananib With or Without Low-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Ixazomib (MLN9708) in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia AML Therapy With Irradiated Allogeneic Cells Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study. Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML)

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

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:

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of complete remission following arsenic trioxide induction

Secondary Outcome

 Median duration of remission

Condition

Adult Acute Megakaryoblastic Leukemia (M7)

Intervention

arsenic trioxide

Study Arms / Comparison Groups

 Treatment (arsenic trioxide)
Description:  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.

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

Drug

Estimated Enrollment

0

Start Date

May 2013


Primary Completion Date

May 2015

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bruno de Medeiros, , 



Administrative Informations


NCT ID

NCT01835288

Organization ID

IRB-26938

Secondary IDs

NCI-2013-00767

Responsible Party

Sponsor

Study Sponsor

Stanford University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Bruno de Medeiros, Principal Investigator, Stanford University


Verification Date

May 2018