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

This study has been completed.

First Received on July 20, 2007. Last Updated on June 30, 2011 History of Changes

Sponsor:	Oslo University Hospital
Collaborators:	St. Olavs Hospital Sorlandet Hospital HF
Information provided by:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00509457

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509457

Locations

Norway
Rikshospitalet - Radiumhospitalet HF
Oslo, Norway

Sponsors and Collaborators

Oslo University Hospital

St. Olavs Hospital

Sorlandet Hospital HF

Investigators

Principal Investigator:

Steinar Aamdal

Oslo University Hospital

More Information

No publications provided

ClinicalTrials.gov 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
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Data Inspectorate; Norway: Directorate for Health and Social Affairs

Keywords provided by Oslo University Hospital:

NSCLC, vaccination
Inoperable NSCLC stage IIIA/B in good performance status

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 13, 2012