Trial | NCT01003808  Report issue

Title

Safety Study of a Recombinant Protein Vaccine to Treat Esophageal Cancer
IMF-001 Phase 1 Study With Refractory Esophageal Tumor

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    imf-001 ...

  • Study Participants

    25
The purpose of this study is to determine the biological recommended dose of IMF-001.
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.
Study Started
Nov 30
2009
Primary Completion
Mar 31
2012
Study Completion
Dec 31
2012
Last Update
Apr 17
2013
Estimate

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 names: CHP-NY-ESO-1

IMF-001 Experimental

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).

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
No Results Posted