Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImmunoFrontier, Inc.
ClinicalTrials.gov Identifier:
NCT01003808
First received: October 16, 2009
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Esophageal Cancer
Biological: IMF-001
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMF-001 Phase 1 Study With Refractory Esophageal Tumor

Resource links provided by NLM:


Further study details as provided by ImmunoFrontier, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: November 2009
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003808

Locations
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
Study Director: Daiju Ichimaru, BSc ImmunoFrontier, Inc.
  More Information

Publications:

Responsible Party: ImmunoFrontier, Inc.
ClinicalTrials.gov Identifier: NCT01003808     History of Changes
Other Study ID Numbers: IMF001J
Study First Received: October 16, 2009
Last Updated: April 16, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014