Prof Lair Zambon
Clinical Pulmonary Service
Department of Internal Medicine
Faculty of Medical Sciences
State University of Campinas.
Rua Tessália Vieira de Camargo
Cidade Universitária Zeferino Vaz
Distrito de Barão Geraldo.
Mature Autologous Dendritic Cell Vaccines in Advanced Non-Small Cell Lung Cancer
To evaluate the feasibility, safety and immunologic responses in use in mature, antigen-pulsed autologous dendritic cell (DC) vaccine in non-small cell lung cancer (NSCLC) patients.
Human Research Ethics Committee from State University of Campinas, 27th September 2005 (ref: 452/2005)
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Non-Small Lung Cancer
1. All selected patients received conventional treatment (chemotherapy with or without radiotherapy).
2. The chemotherapy protocols included paclitaxel 175 mg/m2 and cisplatinum 70 mg/m2 on day 1. These cycles were then repeated four times every 21 days.
3. After the fourth chemotherapy cycle, the patients were submitted to
3.1. computed tomography (CT) scan of thorax, abdomen and brain to evaluate the tumor response
4. Immunization Protocol: a prime vaccine and a single boost were given fifteen days apart. For each dose of vaccine, two aliquots were prepared in separate syringes with saline solution. First, a dose was subcutaneously administered in the arm and after 1 hour the second dose was given intravenously in the other arm. After the second dose, the patient remained under observation for 1 hour for evaluation of immediate unexpected adverse events.
Dendritic Cell Vaccines
Primary outcome measures
1. Measurable immunologic response: The cellular composition of the immune system, before and after vaccination with the dendritic cells, was assessed from peripheral blood samples using flow cytometry. The day of immunisation was considered as Day 0. The peripheral blood samples were collected one week before vaccination (Day -7), two weeks after the first dose of vaccine (Day 14), two weeks after the second dose of vaccine (Day 28) and one month (Day 43) after the end of the vaccination protocol. The lymphoproliferation test was used to assess the ability of dendritic cells to stimulate specific lymphocytes in vivo.
2. Safety was evaluated by the clinical and laboratorial evolution according Cancer Therapy Evaluation Program (CTEP) and Common Terminology Criteria for Adverse Events (CTCAEv3)
Secondary outcome measures
Therapeutic effects of immunotherapy: tumor response to the vaccine was evaluated by RECISTs criteria
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Histopathologically confirmed diagnosis of advanced NSCLC (stage IIIB-IV)
2. Age less than or equal to 70 years
3. Performance status less than or equal to 2
4. No prior chemotherapy, surgery, or radiotherapy
5. No central nervous system metastases
6. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
7. No associated acute disease
8. HLA-A2 phenotype
9. Expression of Wilms Tumor Protein (WT1), Human Epidermal Growth Factor Receptor 2 (HER-2), Carcinoembryonic Antigen (CEA) or Melanoma Antigen 1 (MAGE1) proteins at the tumor site (tissue)
Target number of participants
Participant exclusion criteria
Progressive disease after conventional treatment
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Clinical Pulmonary Service, Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas.
National Council of Scientific and Technological Development (CNPq) (Brazil)
National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Cientifico e Tecnológico [CNPq])
SHIS Quadra 1
Edifício Santos Dumont
National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Cientifico e Tecnológico [CNPq]) (Brazil)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21682877
Perroud MW, Honma HN, Barbeiro AS, Gilli SC, Almeida MT, Vassallo J, Saad ST, Zambon L, Mature autologous dendritic cell vaccines in advanced non-small cell lung cancer: a phase I pilot study., J. Exp. Clin. Cancer Res., 2011, 30, 65, doi: 10.1186/1756-9966-30-65.