Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
This study has been terminated.
(Supporting agency withdrew funding for study.)
Sponsor:
Northwestern University
Collaborators:
CytRx
Cephalon
Information provided by (Responsible Party):
Jessica Altman, Northwestern University
ClinicalTrials.gov Identifier:
NCT00985530
First received: September 25, 2009
Last updated: October 28, 2013
Last verified: October 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Promyelocytic Leukemia |
Drug: Tamibarotene Drug: Arsenic trioxide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
U.S. FDA Resources
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL. [ Time Frame: Once the MTD has been reached. ] [ Designated as safety issue: Yes ]
| Enrollment: | 4 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985530
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985530
Locations
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
Northwestern University
CytRx
Cephalon
More Information
| Responsible Party: | Jessica Altman, Jessica Altman, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00985530 History of Changes |
| Other Study ID Numbers: | NU 08H9 NCI-2010-01852 STU00012159 |
| Study First Received: | September 25, 2009 |
| Last Updated: | October 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms |
Leukemia, Myeloid, Acute Leukemia, Myeloid Arsenic trioxide Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 30, 2016