Resectable, Non-functioning Pituitary Adenoma
Conditions
Keywords
Resectable, non-functioning pituitary adenoma, Pituitary tumor, Pituitary adenoma, Pituitary macroadenoma
Brief summary
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.
Detailed description
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.
Interventions
DRUGFarletuzumab
Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.
Sponsors
Morphotek
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size. | Every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of farletuzumab in this patient population. | Weekly for the first 3 months followed by every 2 weeks for 12 months |
Countries
United States
Outcome results
None listed