Pasireotide Treatment for Patients With Prolactinomas Who Need Treatment Beyond Dopamine Agonist Therapy
Memorial Sloan Kettering Cancer Center
Summary
The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 or older 2. Male and female patients with prolactinomas with at least one of the following criteria: * Clinical intolerance due to adverse events on DA treatment, preventing continued treatment. * Contraindication to DA treatment (e.g., patients requiring dopamine antagonist therapy or other therapy that is contraindicated). * Tumor resistance to DA, defined as \<50% decrease in longest diameter, or progression in tumor size and/or lack of prolactin normalization with at least 2 mg per week, or maximally tolerated dose, of cabergoline or bromocriptine.…
Interventions
- DrugPasireotide
Pasireotide will be initiated at 40 mg IM one time dose and if tolerated dose will be increased to 60 mg IM every 4 weeks +/-7 days.
- OtherSF-36 and HADS
Baseline assessment will be conducted within 30 days of starting treatment, week 12, 24 and week 28.
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York