Phase 1
Completed N=22
NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
Source: ClinicalTrials.gov NCT00299728 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs) — 11; 11; 0; 0 Participants
Summary
This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1.
The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses.
Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible, regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry.
The primary objective of the study was to define safety.
Secondarily, the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein. Blood samples were to be obtained at baseline, prior to each vaccination, one week after each vaccination, and at the last study visit for the assessment of NY-ESO-1-specific CD4+ and CD8+ T cells. Cytokine secretion by NY-ESO-1-specific CD8+ and CD4+ T cells, as a measure of T cell activation, was to be determined by FACS analysis. In addition, humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA.
Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable (measurable and non-measurable) disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs) |
11; 11; 0; 0 | — |
| PRIMARY Number of Subjects With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline. |
1; 0; 10; 7 | — |
| SECONDARY Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Subjects With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ T Cells After in Vitro Stimulation |
10; 7; 1; 0 | — |
| SECONDARY Number of Subjects With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO--Specific CD8+ T Cells After in Vitro Stimulation |
5; 4; 6; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Histological diagnosis of hepatocellular carcinoma, bladder cancer, breast cancer, non-small lung cancer (NSCLC), melanoma, sarcoma, prostate cancer, esophageal cancer, or ovarian cancer, independent of NY-ESO-1 expression in a tumor biopsy.
or
Histological diagnosis of other types of cancers, provided NY-ESO-1 or LAGE-1 expression can be shown in a tumor biopsy.
- At least 4 weeks since surgery prior to first dosing of study agent.
- Laboratory values within the following limits:
- Hemoglobin ≥ 11.0 g/dL
- Neutrophil count ≥ 1.5 x l0^9/L
- Lymphocyte count ≥ lower limit of institutional normal
- Platelet count ≥ 80 x l0^9/L
- Serum creatinine ≤ 2.0 mg/dL
- Serum bilirubin ≤ 2 x upper limit of institutional normal
- AST/ALT ≤ 2 x upper limit of institutional normal
- Patients must have a Karnofsky performance status of ≥70%.
- Life expectancy ≥ 6 months.
- Age ≥ 18 years.
- Able and willing to give witnessed, written informed consent for participation in the trial.
Exclusion Criteria
- 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).
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Previous bone marrow or stem cell transplant.
- History of immunodeficiency disease or autoimmune disease except vitiligo.
- Metastatic disease to the central nervous system, unless treated and stable.
- 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.
- Known HIV, Hepatitis B or Hepatitis C positivity.
- Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose of study agent (6 weeks for nitrosoureas).
- Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
- Pregnancy or lactation.
- Women of childbearing potential not using a medically acceptable means of contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
Data sourced from ClinicalTrials.gov (NCT00299728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.