Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas
The purpose of this study is to evaluate whether therapy with farletuzumab is effective and
 safe in the treatment of resectable, non-functioning pituitary adenomas.
Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by
 the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are > 1 cm
 in size that can cause progressive visual loss, headaches, and symptoms of pituitary
 dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of
 tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete
 surgical resection of the tumor, repeat surgery and external beam radiation therapy may be
 performed. Previous clinical work suggests there may be a role for a folate receptor in the
 treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has
 the potential to be an effective agent against resectable, non-functioning pituitary
 adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to
 determine if therapy with farletuzumab is effective and safe.
Inclusion Criteria:

 -  Males and females >18 years old

 -  Diagnosis of non-functional pituitary adenoma

 -  Able and willing to undergo surgical resection of the pituitary tumor

 -  Significant medical conditions must be well-controlled and stable for at least 30 days
 prior to signing the informed consent form

 Exclusion Criteria:

 -  Presence of clinically significant pituitary apoplexy

 -  Presence of hormone-secreting adenomas

 -  Presence of compressive optic neuropathy due to pituitary tumor

 -  No prior surgical, medical, or radiation therapy in the last 6 months