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GV 1001 Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
St. Olavs Hospital
Sorlandet Hospital HF
Information provided by:
Oslo University Hospital Identifier:
First received: July 20, 2007
Last updated: June 30, 2011
Last verified: September 2009
To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer.

Condition Intervention
Carcinoma, Non-Small-Cell Lung Biological: GV 1001 Telomerase peptide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

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

Secondary Outcome Measures:
  • Number of T cell responders and DTH responders, time to progression of disease

Estimated Enrollment: 20
Study Start Date: November 2006
Study Completion Date: August 2009
Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00509457

Rikshospitalet - Radiumhospitalet HF
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
Sorlandet Hospital HF
Principal Investigator: Steinar Aamdal Oslo University Hospital
  More Information Identifier: NCT00509457     History of Changes
Other Study ID Numbers: 2006-002646 11
2006-50 DNR
Study First Received: July 20, 2007
Last Updated: June 30, 2011

Keywords provided by Oslo University Hospital:
NSCLC, vaccination
Inoperable NSCLC stage IIIA/B in good performance status

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on September 21, 2017