Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer

ImmunoFrontier

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer

Treatments: Biological: IMF-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003808

IMF001J

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

IMF-001

Experimental group

Description:

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).

Treatment:

Biological: IMF-001