Randomised, double blind, placebo-controlled, multi-centre, group-sequential trial of G17DT for patients with advanced pancreatic cancer unsuitable or unwilling to take chemotherapy

Gilliam, Andrew D.; Topuzov, Eldar; Garin, A.; Pulay, I; Broome, P.; Watson, SA; Rowlands, B. J.; Takhar, Arjun; Beckingham, I. J.

doi:10.1200/jco.2004.22.90140.2511

Cited by 9 publications

(5 citation statements)

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“…Immunotherapies, including the granulocyte‐macrophage colony‐stimulating factor gene transduced tumor vaccines (GVAX) trial, mutated KRAS peptide vaccine, and gastrin peptide vaccine for pancreatic cancer, have also been tested and are expected to improve the prognosis of patients with the disease. ( 32–34 ) The quantity of myeloid‐derived suppressor cells was reported to be reduced by gemcitabine treatment in vivo . ( 30 ) Furthermore, gemcitabine was shown to enhance the sensitivity of tumor cells to killing‐mediated CTL and their induction.…”

Section: Discussionmentioning

confidence: 99%

Phase I clinical trial using peptide vaccine for human vascular endothelial growth factor receptor 2 in combination with gemcitabine for patients with advanced pancreatic cancer

et al. 2010

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Vascular endothelial growth factor receptor 2 (VEGFR2) is an essential factor in tumor angiogenesis and in the growth of pancreatic cancer. Immunotherapy using epitope peptide for VEGFR2 (VEGFR2-169) that we identified previously is expected to improve the clinical outcome. Therefore, a phase I clinical trial combining of VEGFR2-169 with gemcitabine was conducted for patients with advanced pancreatic cancer. Patients with metastatic and unresectable pancreatic cancer were eligible for the trial. Gemcitabine was administered at a dose of 1000 mg ⁄ m 2 on days 1, 8, and 15 in a 28-day cycle. The VEGFR2-169 peptide was subcutaneously injected weekly in a dose-escalation manner (doses of 0.5, 1, and 2 mg ⁄ body, six patients ⁄ one cohort). Safety and immunological parameters were assessed. No severe adverse effect of grade 4 or higher was observed. Of the 18 patients who completed at least one course of the treatment, 15 (83%) developed immunological reactions at the injection sites. Specific cytotoxic T lymphocytes (CTL) reacting to the VEGFR2-169 peptide were induced in 11 (61%) of the 18 patients. The disease control rate was 67%, and the median overall survival time was 8.7 months. This combination therapy for pancreatic cancer patients was tolerable at all doses. Peptide-specific CTL could be induced by the VEGFR2-169 peptide vaccine at a high rate, even in combination with gemcitabine. From an immunological point of view, the optimal dose for further clinical trials might be 2 mg ⁄ body or higher. This trial was registered with ClinicalTrial.gov (no.

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Section: Discussionmentioning

confidence: 99%

Phase I clinical trial using peptide vaccine for human vascular endothelial growth factor receptor 2 in combination with gemcitabine for patients with advanced pancreatic cancer

et al. 2010

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“…A randomized clinical trial of 154 patients with advanced pancreatic cancer was well tolerated (2/79 (2.5%) G17DT patients versus 0/74 (0%) placebo patients developed sterile abscess at the injection site). The MS in the G17DT group was 138 days versus 78 days for the control group [Gilliam et al 2004]. Subsequently, a randomized, multicenter, double-blind, placebo-controlled study of 154 patients with advanced pancreatic cancer gave MS of 151 days as compared with 82 days with placebo [Gilliam et al 2012].…”

Section: Whole-cell Vaccinesmentioning

confidence: 99%

Immunotherapy in pancreatic cancer treatment: a new frontier

Thind

Padrnos

Ramanathan

et al. 2016

Therap Adv Gastroenterol

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Pancreatic cancer is a highly aggressive and lethal cancer characterized by high invasiveness, local and extensive dissemination at time of diagnosis and resistance to treatment. Few therapies have shown efficacy in the past and even standard of care therapies yield only modest improvements in the mortality of patients with advanced or metastatic disease. Efforts have been undertaken to study the pancreatic tumor microenvironment and have established its complex and immunosuppressive nature which could explain the high resistance to chemotherapy. Novel therapies targeting the tumor microenvironment with an aim to decrease this resistance, improve immune tolerance and increase the efficacy of the current treatment have shown some promising preliminary results in preclinical and clinical trials. We review the current advances in the field of immunotherapy and their effectiveness as a potential treatment strategy in the pancreatic cancer.

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“…Several proteins, such as carcinoembryonic antigen (CEA), mutated KRAS, mucin-1 (MUC1) and gastrin, have in fact been identified to be specifically overexpressed in most pancreatic cancers [119][120][121][122][123][124][125] antigens were identified over 10 years ago using various methods to analyse gene expression in cancer cells. Vaccines and antibodies designed to target these antigens have been tested in early-phase clinical trials [126][127][128][129][130][131] hese antigens are known to have weak inherent immune potential, various immune-modulating agents were co-administered, including granulocyte-macrophage colony-stimulating factor (GM-CSF), and interleukin-2 (IL-2). So far, a few studies have demonstrated postvaccination immune responses to the relevant peptides or whole proteins.…”

Section: Vaccines Against Pancreatic Tumour Antigensmentioning

confidence: 99%

Pancreatic Cancer - Clinical Management

Srivastava¹

2012

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Randomised, double blind, placebo-controlled, multi-centre, group-sequential trial of G17DT for patients with advanced pancreatic cancer unsuitable or unwilling to take chemotherapy

Cited by 9 publications

References 0 publications

Phase I clinical trial using peptide vaccine for human vascular endothelial growth factor receptor 2 in combination with gemcitabine for patients with advanced pancreatic cancer

Phase I clinical trial using peptide vaccine for human vascular endothelial growth factor receptor 2 in combination with gemcitabine for patients with advanced pancreatic cancer

Immunotherapy in pancreatic cancer treatment: a new frontier

Pancreatic Cancer - Clinical Management

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