A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC)
Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
Participant gender:
Summary
The main purpose of this research study is to determine if a vaccine made from a patient's
lung cancer tumor cells will be effective in making the cancer shrink or disappear. The
vaccine will be given by itself to some patients, while other patients will get the vaccine
with cyclophosphamide (a type of chemotherapy). Studies in animals and other cancer vaccine
trials suggest that cyclophosphamide may make tumor vaccines more potent. This study will try
to determine if vaccine given with or without this chemotherapy is effective in destroying
lung cancer cells. Additionally, the study will collect information on vaccine safety, both
with and without chemotherapy, and whether the vaccine improves lung cancer-related symptoms
(e.g., shortness of breath).
Tumors from surgical resection will be processed and made into a vaccine. Prior to treatment,
patients will be randomized equally to one of two treatment groups, Cohort A and Cohort B.
Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will
be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day
prior to the first, third, and fifth vaccine treatments. Patients will receive intradermal
(beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of
up to five vaccine treatments. The duration of this study, including active follow up, is
approximately two years. After this, patients will be followed-up yearly for a total of 15
years.