Autologous Dendritic Cell Vaccines in Lung Cancer

ISRCTN	ISRCTN45563569
DOI	https://doi.org/10.1186/ISRCTN45563569
Secondary identifying numbers	CAAE: 0245.0.146.000-05

Submission date: 11/02/2011
Registration date: 28/02/2011
Last edited: 03/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Lair Zambon
Scientific

Clinical Pulmonary Service, Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas.
Rua Tessália Vieira de Camargo, 126, Cidade Universitária Zeferino Vaz, Distrito de Barão Geraldo.
Campinas
13083-970
Brazil

Phone	+55 1935217907
Email	lair.zambon@hes.unicamp.br

Study information

Study design	Prospective non-randomised
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Mature Autologous Dendritic Cell Vaccines in Advanced Non-Small Cell Lung Cancer
Study hypothesis	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.
Ethics approval(s)	Human Research Ethics Committee from State University of Campinas, 27th September 2005 (ref: 452/2005)
Condition	Non-Small Lung Cancer
Intervention	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 3.2. Leukapheresis 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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dendritic Cell Vaccines
Primary outcome measure	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 study start date	01/10/2005
Overall study end date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	5
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)
Participant exclusion criteria	Progressive disease after conventional treatment
Recruitment start date	01/10/2005
Recruitment end date	30/04/2009

Locations

Countries of recruitment

Brazil

Study participating centre

Clinical Pulmonary Service, Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas.

Campinas
13083-970
Brazil

Sponsor information

National Council of Scientific and Technological Development (CNPq) (Brazil)
Government

National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Cientifico e Tecnológico [CNPq])
SHIS Quadra 1, Conjunto B, Edifício Santos Dumont, Lago Sul
Brasilia
71605-001
Brazil

Phone	+55 6132119000
Email	atendimento@cnpq.br
Website	http://www.cnpq.br/
"ROR"	https://ror.org/03swz6y49

Funders

Funder type

Government

National Council of Scientific and Technological Development (Conselho Nacional de Desenvolvimento Cientifico e Tecnológico [CNPq]) (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/06/2011		Yes	No