Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Sponsor

Northwestern University (Other)

Overall Status

Terminated

CT.gov ID

NCT00985530

Collaborator

CytRx (Industry), Cephalon (Industry)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Promyelocytic Leukemia	Drug: Tamibarotene Drug: Arsenic trioxide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Tamibarotene + Arsenic Trioxide	Drug: Tamibarotene Self-administered tablets BID (approximately one hour after breakfast & dinner) during each 6 week cycle Drug: Arsenic trioxide Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.

Arm

Intervention/Treatment

Experimental: Arm 1

Tamibarotene + Arsenic Trioxide

Drug: Tamibarotene

Self-administered tablets BID (approximately one hour after breakfast & dinner) during each 6 week cycle

Drug: Arsenic trioxide

Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.

Outcome Measures

Primary Outcome Measures

To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL. [Once the MTD has been reached.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
CytRx
Cephalon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jessica Altman, Jessica Altman, MD, Northwestern University

ClinicalTrials.gov Identifier:

NCT00985530

Other Study ID Numbers:

NU 08H9
NCI-2010-01852
STU00012159

First Posted:

Sep 28, 2009

Last Update Posted:

Oct 30, 2013

Last Verified:

Oct 1, 2013

Additional relevant MeSH terms:

Leukemia

Leukemia, Promyelocytic, Acute

Arsenic Trioxide

Study Results

No Results Posted as of Oct 30, 2013