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

This study has been completed.

First Received: July 20, 2007 Last Updated: September 21, 2009 History of Changes

Sponsor:	Rikshospitalet HF
Collaborators:	St. Olavs Hospital Sorlandet Hospital HF
Information provided by:	Rikshospitalet HF
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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 Rikshospitalet HF:

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

Rikshospitalet HF

St. Olavs Hospital

Sorlandet Hospital HF

Investigators

Principal Investigator:

Steinar Aamdal

Rikshospitalet HF

More Information

No publications provided

Study ID Numbers:	2006-002646 11, 2006-50 DNR
Study First Received:	July 20, 2007
Last Updated:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00509457 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Data Inspectorate; Norway: Directorate for Health and Social Affairs

Keywords provided by Rikshospitalet HF:

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 05, 2009