Closed Clinical Trials at the Cancer Immunology and Immunotherapy Center (CIIC)

Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence (read brochure in greek)

Protocol ID Code: CP-BR-1-2007
National Organization for Medicines ID Code: IS 52/01-03-07
EudraCT Number:  2007-000934-38
ClinicalTrials.gov Identifier:  NCT00524277

Active Immunization (Vaccination) of Patients with Prostate Cancer with a HER-2/neu Synthetic Peptide

A Phase I clinical trial on a novel immunotherapeutic vaccine, AE37, was conducted in collaboration with the Urology Clinic of  Saint Savas Hospital.  The AE37 vaccine is a synthetic HER-2/neu oncogene peptide developed by Antigen Express, Inc. The peptide is designed to stimulate an immune response against tumors expressing the oncoprotein.
The prostate cancer vaccination trial involved 30 patients, monitoring safety and immunological responsiveness to a dose of the vaccine previously shown to be well tolerated in breast cancer patients.

Protocol ID Code: GENEREX-06-07
National Organization for Medicines ID Code: IS107/2006
EudraCT Number:  2006-003299-37

AE37 vaccination in prostate cancer: (i) identification of biomarkers in the context of prognosis and prediction.
This is a retrospective analysis of the data from the AE37 phase I study, which aimed at the identification of biomarkers predicting immunologic and clinical responses to vaccination with AE37. The results from this study (TGFbeta showed an inverse and IFNgamma and DTH showed a direct correlation with immunological responses and overall survival) are submitted for publication to Cancer Immunol Immunother. Longer follow-up of at least some of the patients who received an AE37 booster will show up to which time-point post booster these biomarkers may predict immunity to the vaccine but also clinical efficacy. In any case a phase II study with a homogenous population of prostate cancer patients is necessary to validate these biomarkers.

AE37 vaccination in prostate cancer: (i) identification of HLA-A24 alone and/or CD8+ T cells responding to PSA(152-160) in the context of HLA-A24, as prognostic and predictive biomarkers.

This project is based on preliminary showing that patients expressing the HLA-A24 allele have increased frequencies of CD8+ T lymphocytes in their peripheral blood which are stained positively with a HLA-A24/PSA(152-160) dextramer. These patients also proved to respond to the AE37 vaccine in the AE37 phase I prostate cancer study and also had improved survival. We are planning to stratify minimally symptomatic or asymptomatic castrate-resistant metastatic prostate cancer patients (CRMPCaP) based on the expression of this allele and to assess their predicted overall survival (POS) according to the Halabi nomogram (ie, HLA-A24+ vs HLA-A24-). Moreover, the group of HLA-A24+ patients will be subgrouped in those who have increased vs those with decreased frequencies of HLA-A24/PSA(152-160) dextramer+ CD8+ T cells and POS will be assessed in both groups.

Adoptive Transfer of Activated Natural Killer Cells for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer
A phase I clinical trial, monitoring safety and possible therapeutic potential of the administration of allogenic, ex vivo expanded NK cells in patients with advanced non-small cell lung cancer (NSLC).  Two to four doses of NK cells by intravenous injection in conjuction with conventional chemotherapy were administered to 16 recipients.  NK cells originated from close family members were activated and cultured in the presence of IL15 and hydrocortisone.

Protocol ID Code: PEP-CP-08-05

National Organization for Medicines ID Code: IS 89/2006

EudraCT Number:  2005-005125-58