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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

This study has been terminated.
(Supporting agency withdrew funding for study.)
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00985530
First received: September 25, 2009
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  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:

MedlinePlus related topics: Arsenic Leukemia
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
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
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
  More Information

No publications provided

Responsible Party: Jessica Altman, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00985530     History of Changes
Other Study ID Numbers: NU 08H9
Study First Received: September 25, 2009
Last Updated: May 18, 2011
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
Benzoates
 Arsenic trioxide
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013