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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509457
• Other study ID #: 2006-002646 11
• Secondary ID: 2006-50 DNR
• Status: Completed
• Phase: N/A
• First received: July 20, 2007
• Last updated: June 30, 2011
• Start date: November 2006
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Data Protection AuthorityNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Biological:
• GV 1001 Telomerase peptide

Locations

Country	Name	City	State
Norway	Rikshospitalet - Radiumhospitalet HF	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Sorlandet Hospital HF, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine if combined chemoradiotherapy in patients with NSCLC followed by vaccination( immunotherapy) will increase the immunological response compared to previous experience
Secondary	Number of T cell responders and DTH responders, time to progression of disease