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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098085
• Other study ID #: C-100-26
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2004
• Last updated: March 6, 2009
• Start date: September 2003

Study information

• Verified date: March 2009
• Source: Agenus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma
• Pulmonary Cancer

Intervention

Biological:
• HSPPC-96

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Agenus, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.