Condition category
Cancer
Date applied
11/02/2011
Date assigned
28/02/2011
Last edited
03/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lair Zambon

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAAE: 0245.0.146.000-05

Study information

Scientific title

Mature Autologous Dendritic Cell Vaccines in Advanced Non-Small Cell Lung Cancer

Acronym

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

Human Research Ethics Committee from State University of Campinas, 27th September 2005 (ref: 452/2005)

Study design

Prospective non-randomised

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

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 RECIST’s criteria

Overall trial start date

01/10/2005

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

5

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

Trial participating centre

Clinical Pulmonary Service, Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas.
Campinas
13083-970
Brazil

Sponsor information

Organisation

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

Sponsor details

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
+55 6132119000
atendimento@cnpq.br

Sponsor type

Government

Website

http://www.cnpq.br/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21682877

Publication citations

  1. Results

    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.

Additional files

Editorial Notes