Brief Title
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
Official Title
A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia
Brief Summary
Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial
treatment or has not gone away with initial therapy. This research study involves testing an
investigational drug called Tamibarotene in combination with standard treatment for relapsed
APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with
relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans
retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA
and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia
cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of
this study is to determine if tamibarotene in combination with arsenic trioxide is safe and
effective.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.
Condition
Acute Promyelocytic Leukemia
Intervention
Tamibarotene
Study Arms / Comparison Groups
Arm 1
Description: Tamibarotene + Arsenic Trioxide
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
4
Start Date
October 2009
Completion Date
May 2011
Primary Completion Date
May 2011
Eligibility Criteria
Inclusion Criteria:
- Must have diagnosis of relapsed APL
- Must have completed any prior cancer treatment at least 6 months prior to study
- Must have had prior treatment that included ATRA
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00985530
Organization ID
NU 08H9
Secondary IDs
NCI-2010-01852
Responsible Party
Principal Investigator
Study Sponsor
Northwestern University
Collaborators
CytRx
Study Sponsor
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Verification Date
October 2013