A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigen

A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigen - NY-ESO-1 protein with Poly ICLC cancer vaccine

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007954

Enrollment

Registered

2012-05-21

Start date

2012-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with NY-ESO-1-expressing advanced esophageal cancer, gastric cancer, lung cancer and malignant melanoma

Interventions

NY-ESO-1 protein 200 microgram Montanide ISA-51 NY-ESO-1 protein 200microgram OK432 Poly-ICLC NY-ESO-1 protein 200 microgram Montanide ISA-51 Poly-ICLC NY-ESO-1 protein 200 microgram Montanid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological diagnosis of any type of cancers expressing NY-ESO-1 antigen. 2. At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent. 3. Laboratory values within the following limits: Hemoglobin > 8.0 g/dL Lymphocyte count 2,000/mm3 Platelet count 75,000/mm3 Serum creatinine 2.5 mg/dL Serum bilirubin 2.0 mg/dl AST/ALT 150 IU/l 4. Patients must have a ECOG performance status of 0-2. 5. Life expectancy 4 months. 6. Age 20 years. 7. Able and willing to give witnessed, written informed consent for participation in the trial (see Section 12.2) 8. Without allergy against Penicillin

Exclusion criteria

Exclusion criteria: 1. Clinically significant heart disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias). 2. Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders. 3. Previous bone marrow or stem cell transplant. 4. History of immunodeficiency disease or autoimmune disease except vitiligo. 5. Metastatic disease to the central nervous system, unless treated and stable. 6. Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ. 7. Known HIV, positivity. 8. Concomitant treatment with steroids. Topical or inhalational steroids are permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'.) 9. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent. 10. Pregnancy or lactation. 11. Women of childbearing potential not using a medically acceptable means of contraception. 12. Psychiatric or addictive disorders that may compromise the ability to give informed consent. 13. Lack of availability of the patient for immunological and clinical follow-up assessment.

Design outcomes

Primary

Measure	Time frame
Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.	—

Secondary

Measure	Time frame
Humoral: NY-ESO-1 reactive antibodies measured by ELISA. Cellular: NY-ESO-1 specific CD4 and CD8 T-cells by cytokine secretion as determined by FACS analysis or ELISPOT assay. Tumor response will be assessed according to the Response Evaluation	—

Countries

Japan

Contacts

Public ContactHisashi Wada

Osaka University Graduate School of Medicine Gastroenterological Surgery

hwada@gesurg.med.osaka-u.ac.jp0668793251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026