GV 1001 Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Not Applicable
Completed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00509457
- Lead Sponsor
- Oslo University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of T cell responders and DTH responders, time to progression of disease
Trial Locations
- Locations (1)
Rikshospitalet - Radiumhospitalet HF
🇳🇴Oslo, Norway