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Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

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: NCT01003808
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
ImmunoFrontier, Inc.

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE November 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
To evaluate the maximum tolerated dose, dose-limiting toxicities, type/frequency/degree of adverse events and NY-ESO-1 antigen-specific immune response of IMF-001 alone in patients with esophageal cancer. [ Time Frame: First 12 weeks (during the first 6 injections) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
To evaluate clinical activity (tumor response and time to progression). [ Time Frame: Up to 2 years, or until progression of PS or no positive immune response from IMF-001. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer
Official Title  ICMJE IMF-001 Phase 1 Study With Refractory Esophageal Tumor
Brief Summary The purpose of this study is to determine the biological recommended dose of IMF-001.
Detailed Description The prognosis of esophageal cancer is improved with the improvement of surgery, chemotherapy and radiation therapy. However, there are no standard therapies established for recurrent esophageal cancer. NY-ESO-1 antigen is expressed in 33% of patients. NY-ESO-1 protein is applicable without limitation by HLA types, and injected as a complex with cholesteryl pullulan (CHP), forming nano-particles (IMF-001), it can activate both CD4+ and CD8+ T cells. In this phase 1 study, the safety and the biological recommended dose will be determined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE Biological: IMF-001
100 or 200 mcg, subcutaneously every 2 weeks. Number of Injections: 6 times. (The treatment may be continued if it is beneficial to the subject).
Other Name: CHP-NY-ESO-1
Study Arms  ICMJE Experimental: IMF-001
100 or 200 mcg, subcutaneously every 2 weeks. Number of Injections: 6 times. (The treatment may be continued if it is beneficial to the subject).
Intervention: Biological: IMF-001
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2009)
20
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Radically unresectable stage III/IV esophageal tumors that have failed the standard treatment (including chemotherapy and radiotherapy), recurrent metastasis after radical surgery and not responding to the standard treatments, or recurrent metastasis after radiotherapy before/after radical surgery.
  • Primary esophageal tumors confirmed by pathological diagnosis
  • Tumor cells expressing NY-ESO-1 antigen (by tissue-immunostaining method or quantitative RT-PCR method)
  • Performance status (PS) of 0, 1 or 2 (ECOG Scale)
  • Life expectancy >/= 4 months
  • No serious disorders with major organs (bone marrow, heart, lung, liver and kidney) and meets the following criteria:

    • WBC count >/= 2.0 x 10 9/L
    • Hemoglobin >/=8.0g/dL
    • Platelet count >/=75 x 10 9/L
    • Serum total bilirubin: </=1.5 x ULN (3 x ULN if with liver mets)
    • AST and ALT: </=2.5 x ULN (5x ULN if with liver mets)
    • Serum creatinine: </=1.5x ULN
  • Agree to use birth control including condoms from the time of obtaining the consent to 6 months after the final administration of the study drug [except females after menopause (1 year or more after the last menstruation and females/males after an operation for sterilization)]
  • Given written informed consent

Exclusion Criteria:

  • HIV antibody positive
  • Double cancer
  • History of autoimmune disease
  • History of severe anaphylaxis
  • Active metastatic disease in the central nervous system (CNS) Within 4 weeks after treatment with an anti-tumor agent, systemically administered adrenocorticosteroids, immune suppressants or immune enhancers
  • Pregnant or lactating
  • Any other inadequacy for this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01003808
Other Study ID Numbers  ICMJE IMF001J
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ImmunoFrontier, Inc.
Study Sponsor  ICMJE ImmunoFrontier, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daiju Ichimaru, BSc ImmunoFrontier, Inc.
PRS Account ImmunoFrontier, Inc.
Verification Date April 2013

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