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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




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