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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509457
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : July 1, 2011
St. Olavs Hospital
Sorlandet Hospital HF
Information provided by:
Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: GV 1001 Telomerase peptide Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : November 2006
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Number of T cell responders and DTH responders, time to progression of disease

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00509457     History of Changes
Other Study ID Numbers: 2006-002646 11
2006-50 DNR
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: September 2009

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