Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer

March 6, 2009 updated by: Agenus Inc.

A Phase II Study of the Feasibility to Derive Autologous Vaccine (HSPPC-96) From Tumor Tissue for Clinical Administration in Patients With Resectable Non-Small Cell Lung Cancer

Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.

Vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.

All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival.

The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.

The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients receiving, and to evaluate overall survival in patients receiving HSPPC-96.

HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine. This vaccine may help the patient's immune system attack cancerous cells while leaving healthy cells alone.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

This is a summary of criteria. Only the Principal Investigator can determine eligibility.

Inclusion Criteria:

  • Suspected non-small cell lung cancer, Stage IB, Stage II, or Stage IIIA
  • Tumor size > 3x3 cm or equivalent to a 9 cm² lesion
  • Scheduled surgery with curative intent
  • At least 18 years of age
  • Must not be pregnant or breast feeding
  • Agree to not receive any other investigative agent at any time while enrolled in this study

Exclusion Criteria:

  • Previous treatment for non-small cell lung cancer
  • Clinical signs or symptoms of brain metastases
  • History of immune suppression or autoimmune disorder
  • Severe active infection or other serious medical illness, that in the opinion of the Principal Investigator, would prevent study completion
  • Other malignancies in the past 5 years, except adequately treated in situ cervix carcinoma or non-melanoma skin cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.

Secondary Outcome Measures

Outcome Measure
The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients, and to evaluate overall survival in patients receiving HSPPC-96.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agenus Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

December 3, 2004

First Submitted That Met QC Criteria

December 3, 2004

First Posted (ESTIMATE)

December 6, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-100-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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