Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00098085
First received: December 3, 2004
Last updated: March 6, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
Lung Cancer
Pulmonary Cancer
Biological: HSPPC-96
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Agenus, Inc.:

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.

Estimated Enrollment: 20
Study Start Date: September 2003
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098085

Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Agenus, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00098085     History of Changes
Other Study ID Numbers: C-100-26
Study First Received: December 3, 2004
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Agenus, Inc.:
Lung cancer
Non-small cell lung cancer
Pulmonary
Immunotherapy
Vaccine

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014