CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Vaccine Treatment +2 morebiological
Likely dose
Cyclophosphamide 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00601796
NCT00601796Phase 2Completed
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Combination Immunotherapy for Lung Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jan 28, 2008·Updated May 24, 2013

In Brief

A Phase 2 clinical trial evaluating Vaccine Treatment, Cyclophosphamide, and 1 other intervention for Lung Cancer. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartOct 1, 2006
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 18.4 years ago

Interventions

Vaccine Treatmentbiological

We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.

Cyclophosphamidedrug

Cyclophosphamide (300 mg/m\^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.

All-trans retinoic acid (ATRA)drug

All-trans retinoic acid was given (150/mg/m\^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.