MedTrace Logo

Immunization of Patients With Non Small Cell Lung Cancer (NSCLC)

NCT00793208 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-12

No results posted yet for this study

Summary

The study of the vaccine will proceed in two stages after the method of Simon (102). In the first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic responses occur, the study will be terminated. If 3 or more responses are observed, the study will proceed to the second stage, accruing an additional 22 patients. If the second stage is complete and a total of 9 or more immunologic responses are observed among the 37 patients treated, the treatment response rate for the vaccine will be considered high enough to warrant further study. Conversely, if the evaluation of the vaccine concludes at the first stage, or if 8 or fewer total immunologic responses occur after completing the second stage, the vaccine will not be considered for further study.

Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Interventions

BIOLOGICAL

semi-allogeneic human fibroblasts (MRC-5) transfected with DNA

Each vaccine consists of 1 x 10e7 DNA-transfected irradiated fibroblasts. A total of 4 weekly immunizations will be delivered to each patient. Each vaccine will be administered i.d. using a 1 mL syringe and a 25 gauge needle. Subjects will have immunizations administered at 4 different sites for each vaccination as follows: Site #1: Right arm Site #2: Left arm Site #3: Right thigh Site #4: Left thigh Approximately equal numbers of transfected fibroblasts will be administered at each site.

Sponsors & Collaborators

  • Immune Cell Therapy Inc.

    collaborator INDUSTRY

  • Theresa Whiteside, PhD

    lead OTHER

Principal Investigators

  • Mark A Socinski, MD · UPCI/UPMC: Director, Lung Cancer Section, Division of Hematology/Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-09-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00793208 on ClinicalTrials.gov