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

Tracking Information

First Received Date ^ICMJE

July 20, 2007

Last Updated Date

September 21, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00509457 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of T cell responders and DTH responders, time to progression of disease

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Biological: GV 1001 Telomerase peptide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00509457

Responsible Party

Study ID Numbers ^ICMJE

2006-002646 11, 2006-50 DNR

Study Sponsor ^ICMJE

Rikshospitalet HF

Collaborators ^ICMJE

St. Olavs Hospital
Sorlandet Hospital HF

Investigators ^ICMJE

Principal Investigator:

Steinar Aamdal

Rikshospitalet HF

Information Provided By

Rikshospitalet HF

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP