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A Cancer Vaccine (CG8123) Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

2014-08-27 03:54:09 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

CG8123, Cyclophosphamide

Status

Completed

Source

Cell Genesys

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:09-0400

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Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

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