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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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.
United States: Food and Drug Administration
C-100-26
NCT00098085
September 2003
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