Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Meningeal Carcinomatosis

Neoplastic Processes

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.

The first 3 patients will be enrolled at dose level 30Gy (RBE) in 3Gy(RBE) fractions. If 1 or fewer patients develop dose-limiting toxicity (DLT), 3 additional patients will be enrolled. If 1 or fewer of the 6 patients experiences a DLT, the trial will proceed to the dose expansion cohort at 30Gy (RBE) . In contrast, if 2 or more patients experience a treatment DLT, 3 patients will be enrolled at dose level 25Gy (RBE) in 2.5Gy(RBE) fractions. If 1 or fewer patients develop a DLT, an additional three patients will be enrolled. If 2 or more patients experience a DLT at 25Gy, the study will be stopped. If 1 or fewer patients develop a DLT in these 6 patients, the trial will proceed to the dose expansion cohort at 25Gy (RBE) and the 6 patients who were treated in Phase Ib will be included in full assessment of safety and efficacy.

Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.

Proton craniospinal irradiation (CSI)

Daniel Higginson, MD

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.

Single-arm, prospective trial with 3+3 dose de-escalation and dose expansion cohort.

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

will be assessed by physician-graded CTCEAv4

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases	NCT03520504	Leptomeningeal ...	Proton craniosp...	10 Years -	Memorial Sloan Kettering Cancer Center
Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases	NCT03520504	Leptomeningeal ...	Proton craniosp...	10 Years -	Memorial Sloan Kettering Cancer Center
Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases	NCT03520504	Leptomeningeal ...	Proton craniosp...	10 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for craniospinal irradiation (csi)