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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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 Summary:

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.

Sponsor: Stanford University

Current Primary Outcome: Rate of complete remission following arsenic trioxide induction [ Time Frame: After 4 weeks of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Median duration of remission [ Time Frame: Time from documented complete remission until time of disease relapse, assessed up to 2 years ]

Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: April 15, 2013
Date Started: May 2013
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016