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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

December 3, 2004
March 6, 2009
September 2003
November 2007   (final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00098085 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer
  • Pulmonary Cancer
Biological: HSPPC-96
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00098085
C-100-26
Not Provided
Not Provided
Agenus, Inc.
Not Provided
Not Provided
Agenus, Inc.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP