NCT03520504

Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases

A Phase Ib Study With Dose Expansion Cohort of Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find the safest and most effective dose for delivering proton beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal metastases. The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the metastasized tumor cells are causing symptoms, would improve the treatment of this disease.

Conditions

• Leptomeningeal Metastases

Interventions

Type	Name	Description
RADIATION	Proton craniospinal irradiation (CSI)	Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.

Timeline

• Start date: 2018-04-26
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2018-05-09
• Last updated: 2022-12-23

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study