Single-Arm Phase II Study of Stereotactic Body Radiation Therapy Concurrent with Nelfinavir for Oligometastases
To determine the 6-month freedom from local progression rate of the radiosensitizer Nelfinavir used concurrently with 15 Gy of stereotactic body radiation therapy (SBRT) delivered in 1 fraction (per lesion site) in patients with oligometastatic disease.
Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment.
In general metastatic disease carries an extremely high mortality rate. Current therapies provide only partial palliation of symptoms and mild to moderate prolongation of survival. Patients are rarely cured of this disease; consequently, better treatment is clearly needed. The proposed treatment represents a logical extension of the current state-of-the-art radiation therapy. It has the potential to translate into more effective palliation and longer patient survival. Another advantage to the patient is that several weeks of radiation therapy can be accomplished in a single day, which is not inconsequential for patients with a limited life expectancy.Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.
09/02/2014 04:02 AM