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

University of Oslo (UIO)

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Biological: GV 1001 Telomerase peptide

Study type: Interventional

Funder types: Other

Identifiers

NCT00509457

2006-50 DNR

2006-002646 11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)