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

Sponsor

Agenus Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00098085

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma Lung Cancer Pulmonary Cancer	Biological: HSPPC-96	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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