CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
autologous dendritic cell cancer vaccinebiological
Likely dose
Autologous dendritic cell vaccine given by subcutaneous injection in front upper thigh; two vaccine injections total, given one month apartAI-extracted
Key inclusion· 8
  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Completely resected stage I-IIIB disease with surgery >4 weeks but ≤4 years ago, OR unresectable stage IIIA/IIIB disease previously treated with definitive radiotherapy or chemotherapy >6 weeks ago
  • Clinically stable disease on imaging within 6 weeks with no progressive disease
  • No malignant pleural or pericardial effusions
Key exclusion· 8
  • No known HIV positivity or other immunosuppressive disorders
  • No significant cardiac disease including NYHA class III-IV heart failure, hemodynamically significant valvular disease, MI within 6 months, active angina, uncontrolled arrhythmia, stroke within 1 year, or cerebrovascular disease
  • No known history of infectious hepatitis
  • No concurrent chemotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00103116
NCT00103116Phase 2Completed

Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)

Edward Hirschowitz·interventional·Posted Feb 8, 2005·Updated Apr 4, 2017

In Brief

A Phase 2 clinical trial evaluating autologous dendritic cell cancer vaccine for Lung Cancer. Completed, enrolled 32 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2005
Enrollment StartOct 1, 2004
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.4 years ago

Interventions

autologous dendritic cell cancer vaccinebiological

Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.