GV 1001 Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) - Full Text View

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

This study is currently recruiting participants.
Verified by Rikshospitalet-Radiumhospitalet HF, July 2007

Sponsors and Collaborators:	Rikshospitalet-Radiumhospitalet HF St. Olavs Hospital Sorlandet Hospital HF
Information provided by:	Rikshospitalet-Radiumhospitalet 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

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

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

Further study details as provided by Rikshospitalet-Radiumhospitalet 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
Estimated Study Completion Date:	March 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

Contacts


Contact: Paal Fr Brunsvig, MD	+4722934000	p.f.brunsvig@medisin.uio.no

Locations


Norway
	Rikshospitalet - Radiumhospitalet HF	Recruiting
	Oslo, Norway
	Contact: Paal Brunsvig, MD +4722934000 p.f.brunsvig@medisin.uio.no
	Principal Investigator: Steinar Aamdal

Sponsors and Collaborators

Rikshospitalet-Radiumhospitalet HF

St. Olavs Hospital

Sorlandet Hospital HF

Investigators


Principal Investigator:	Steinar Aamdal	Rikshospitalet-Radiumhospitalet HF

More Information

Study ID Numbers:	2006-002646 11, 2006-50 DNR
First Received:	July 20, 2007
Last Updated:	July 30, 2007
ClinicalTrials.gov Identifier:	NCT00509457
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Data Inspectorate; Norway: Directorate for Health and Social Affairs

Keywords provided by Rikshospitalet-Radiumhospitalet HF:

NSCLC, vaccination

Inoperable NSCLC stage IIIA/B in good performance status

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 10, 2008