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
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, see Learn About Clinical Studies.

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 September 22, 2014