Trials / Withdrawn
WithdrawnNCT01835288
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase II Study of Arsenic Trioxide in Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Mutated Nucleophosmin 1 (NPM1) Gene
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | arsenic trioxide | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2015-05-01
- First posted
- 2013-04-18
- Last updated
- 2018-05-21
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01835288. Inclusion in this directory is not an endorsement.