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Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 25, 2009
First Posted Date  ICMJE September 28, 2009
Last Update Posted Date October 30, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
Official Title  ICMJE A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Promyelocytic Leukemia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Arm 1
Tamibarotene + Arsenic Trioxide
Interventions:
  • Drug: Tamibarotene
  • Drug: Arsenic trioxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 18, 2011)
4
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2009)
22
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985530
Other Study ID Numbers  ICMJE NU 08H9
NCI-2010-01852 ( Other Identifier: NCI CTRP# )
STU00012159 ( Other Identifier: Northwestern University IRB# )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jessica Altman, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • CytRx
  • Cephalon
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP