Autologous Dendritic Cell Vaccines in Lung Cancer

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45563569

Enrollment

Registered

2011-02-28

Start date

2005-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Lung Cancer Cancer Non-Small Lung Cancer

Interventions

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. Th

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: Progressive disease after conventional treatment

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
Therapeutic effects of immunotherapy: tumor response to the vaccine was evaluated by RECIST?s criteria	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026