Esophageal Cancer
Conditions
Brief summary
The purpose of this study is to determine the biological recommended dose of IMF-001.
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.
Interventions
BIOLOGICALIMF-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).
Sponsors
ImmunoFrontier, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | First 12 weeks (during the first 6 injections) |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate clinical activity (tumor response and time to progression). | Up to 2 years, or until progression of PS or no positive immune response from IMF-001. |
Countries
Japan
Outcome results
None listed