Skip to main content
OpenTrials
Completed

NCT Number: NCT01003808

Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMF-001

Biological

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 names: CHP-NY-ESO-1

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ImmunoFrontier, Inc.

Industry

Registry information

Official study title

IMF-001 Phase 1 Study With Refractory Esophageal Tumor

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 29, 2009
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.