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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma, Lung Cancer, Pulmonary Cancer

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Trial Information

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.

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.


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

Type of Study:

Interventional

Study Design:

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

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.

Authority:

United States: Food and Drug Administration

Study ID:

C-100-26

NCT ID:

NCT00098085

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer
  • Pulmonary Cancer
  • Lung cancer
  • Non-small cell lung cancer
  • Pulmonary
  • Immunotherapy
  • Vaccine
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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