NCT00509457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 1, 2011

Status Verified

September 1, 2009

First QC Date

July 20, 2007

Last Update Submit

June 30, 2011

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC, vaccinationInoperable NSCLC stage IIIA/B in good performance status

Outcome Measures

Primary Outcomes (1)

  • To examine if combined chemoradiotherapy in patients with NSCLC followed by vaccination( immunotherapy) will increase the immunological response compared to previous experience

Secondary Outcomes (1)

  • Number of T cell responders and DTH responders, time to progression of disease

Interventions

GV 1001 Telomerase peptideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet - Radiumhospitalet HF

Oslo, Norway

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Steinar Aamdal

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 31, 2007

Study Start

November 1, 2006

Study Completion

August 1, 2009

Last Updated

July 1, 2011

Record last verified: 2009-09

Locations

NO(1)