Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Brief Summary:
The purpose of this study is to determine the biological recommended dose of IMF-001.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Biological: IMF-001 Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMF-001 Phase 1 Study With Refractory Esophageal Tumor
Study Start Date : November 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01003808


Locations
Layout table for location information
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
Mie University Hospital
TSU, Mie, Japan, 514-8507
Kitano Hospital
Kitano Hospital, Osaka, Japan, 530-8480
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
ImmunoFrontier, Inc.
Investigators
Layout table for investigator information
Study Director: Daiju Ichimaru, BSc ImmunoFrontier, Inc.
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ImmunoFrontier, Inc.
ClinicalTrials.gov Identifier: NCT01003808    
Other Study ID Numbers: IMF001J
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases