New Vaccine Trial GP96

[RandyW]

Phase I/II Study of Ig-gp96 Based Vaccine Against Lung Cancer

This study is not yet open for patient recruitment.

Verified by Hadassah Medical Organization October 2005

Sponsors and Collaborators: Hadassah Medical Organization

Sylvester Cancer Center

Information provided by: Hadassah Medical Organization

ClinicalTrials.gov Identifier: NCT00247065

Purpose

This is a University of Miami initated Proteocol which is based upon the usage of irradiated nonsmall cell lung cancer cells manipulated to express and secrete gp-96to enhance its tumoregenecity. Condition Intervention Phase

Carcinoma, Non-Small-Cell Lung

Vaccine: gp-96-ig expressing irradiated canrcinoma cell vaccine

Phase I

Phase II

MedlinePlus related topics: Lung Cancer

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (stageIIIb),Relapsed or Metstatic (Stage IV) Non Small Cell Lung Cancer Patietns Who Have Failed First Line Chemotherapy(IL)

Further study details as provided by Hadassah Medical Organization:Primary Outcomes: CD8+ T cell responses

Secondary Outcomes: survival

Expected Total Enrollment: 15 Study start: December 2007; Expected completion: December 2008

Last follow-up: December 2007; Data entry closure: December 2007

Lung cancer cells were engineered in Miami to secrete gp-96 -ig. the secretion of this heat shock-ig fusion protein allowed formulation of efficienet antitumor vaccines in mice. The same cell line of lung cancer has been used to efficiently induce immunogenic responses in patients with lung cancer when transfected with B7-1 and HLA-1. In mice Gp-ig based vaccines seem to be able to induce the immune system better than B7-1 based vaccines. Thus it is possible that ig-gp96 vaccines will also prove more effectivein humans.Irradiated engineered cells will be used for vaccination post chemotherapy and immunological and clinical responses will be monitored.Partof the patients will be treated in Israel in a similar manner to that perforemd in the USA.

The study has been authorized in the United states by the FDA Grantor: CBER IND/IDE Number: BB-IND-10940 Serial Number: 1068124

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both CriteriaInclusion Criteria:

patients suffering from nonsmall cell lung cancer after achieving maximal response from first line chemotherapy

Exclusion Criteria:

under 18 ecog less than 4 autoimmune diseases concurrent cancers pregnancy

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00247065

Israel

Oncologly department Hadassah Ein kerem, Jerusalem, 91120, Israel

Liora Mazkira 972-2-6777825 Hovavnech@hadassa.org.il

Hovav nechushtan, Md/Phd, Principal Investigator

Study chairs or principal investigators

hovav nechushtan, md/pHd, Principal Investigator, Hadassah medical center More Information

Publications

Raez LE, Cassileth PA, Schlesselman JJ, Sridhar K, Padmanabhan S, Fisher EZ, Baldie PA, Podack ER. Allogeneic vaccination with a B7.1 HLA-A gene-modified adenocarcinoma cell line in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2800-7.

Study ID Numbers: SCCC2002041(il)

Last Updated: December 12, 2005

Record first received: October 31, 2005

ClinicalTrials.gov Identifier: NCT00247065

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on 2006-05-18

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