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Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC). A Phase II Study of GV 1001 Telomerase Peptide Vaccination in Patients With Locally Advanced NSCLC


N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC). A Phase II Study of GV 1001 Telomerase Peptide Vaccination in Patients With Locally Advanced NSCLC


Survival in patients with locally advanced, inoperable NSCLC may be improved if local
control can be achieved with concurrent chemo radiotherapy .After completed standard
chemo-and radiation therapy; the safety and efficacy of vaccination therapy will be measured
as time to progression after treatment with GV1001. Analysis of changes in T-cell
subpopulations and cytokines in peripheral blood will be performed.


Inclusion Criteria:



- Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received
concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x
30 within the last 4 weeks.

- No sign of brain metastasis( excluded by MRI of the brain)

- Male or female above the age of 18 years.

- Normal lab. values

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To examine if combined chemoradiotherapy in patients with NSCLC followed by vaccination( immunotherapy) will increase the immunological response compared to previous experience

Principal Investigator

Steinar Aamdal

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital

Authority:

Norway: Norwegian Medicines Agency

Study ID:

2006-002646 11

NCT ID:

NCT00509457

Start Date:

November 2006

Completion Date:

August 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • NSCLC, vaccination
  • Inoperable NSCLC stage IIIA/B in good performance status
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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