Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00985530
• Other study ID #: NU 08H9
• Secondary ID: NCI-2010-01852ST
• Status: Terminated
• Phase: Phase 1
• First received: September 25, 2009
• Last updated: October 28, 2013
• Start date: October 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Cephalon, CytRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes