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