Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

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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

, , 

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

, , 


Verification Date

October 2013