Spots Global Cancer Trial Database for Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
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
Study ID: NCT01835288
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Bruno de Medeiros
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
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