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A Phase II Study of Imprime PGG® Injection in Combination with Cetuximab in Patients with Stage IV KRAS-Mutated Colorectal Cancer
[Protocol 09-052]
- Full Title :
- A PHASE II EFFICACY AND SAFETY, OPEN-LABEL, MULTICENTER STUDY OF IMPRIME PGG INJECTION IN COMBINATION WITH CETUXIMAB IN SUBJECTS WITH STAGE IV KRAS-MUTATED COLORECTAL CANCER.
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of the Imprime PGG injection combined with cetuximab (Erbitux®) in patients with metastatic colorectal cancer that contains a mutated form of the KRAS gene.
Cetuximab is a monoclonal antibody approved for the treatment of advanced colorectal cancer. It works by attaching to a site on cancer cells called the epidermal growth factor receptor. Imprime PGG is a glucan, a type of carbohydrate extracted from yeast. Laboratory studies suggest that cetuximab plus Imprime PGG may work together to stimulate the immune system against cancer.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of stage IV colorectal cancer that has progressed despite irinotecan and oxaliplatin therapy and contains a KRAS mutation.
- At least 30 days must have passed since completion of prior treatment, and patients must have recovered from any side effects.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Neil H. Segal at 212-639-6237.
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