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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00985530
Recruitment Status : Terminated (Supporting agency withdrew funding for study.)
First Posted : September 28, 2009
Last Update Posted : October 30, 2013
Sponsor:
Collaborators:
CytRx
Cephalon
Information provided by (Responsible Party):
Jessica Altman, Northwestern University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic Leukemia
U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985530


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
CytRx
Cephalon
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( Other Identifier: NCI CTRP# )
STU00012159 ( Other Identifier: Northwestern University IRB# )
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
 Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic trioxide
Antineoplastic Agents