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.
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
Drug | Synonyms | Arms |
---|
arsenic trioxide | Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox | Treatment (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
Name | Type | Description | Interventions |
---|
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. | |
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 |
Last Updated
May 21, 2018