← Back to Search

Proton Beam Therapy

Proton craniospinal irradiation (CSI) for Metastases

Phase 1

Waitlist Available

Led By T. Jonathan Yang, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether proton beam radiation can improve treatment for leptomeningeal metastases by targeting the CSF, brain, and spinal cord.

Eligible Conditions

Metastases

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

number of patients with dose-limiting toxicity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Proton RadiationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton craniospinal irradiation (CSI)

2018

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,831 Total Patients Enrolled

2 Trials studying Metastases

384 Patients Enrolled for Metastases

T. Jonathan Yang, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

268 Total Patients Enrolled

Daniel Higginson, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

54 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers currently being recruited for this experiment?

"Clinicaltrials.gov states that this medical trial is no longer enrolling patients, as the original post date was April 26th 2018 and its most recent update occurred on June 28th 2022. However, 638 other clinical studies are in need of participants at present."

Answered by AI

How many medical centers are presently conducting this investigation?

"Patients can enroll in this trial at 10 different sites. For example, Memorial Sloan Kettering Monmouth is located in Middletown, while Memorial Sloan Kettering Commack and Memoral Sloan Kettering Westchester are both situated in Harrison. There are 7 other locations as well."

Answered by AI

Are there any potential health risks associated with Proton craniospinal irradiation (CSI) treatment?

"Our internal evaluation at Power has assigned a score of 1 to Proton Craniospinal Irradiation (CSI) due to its Phase 1 status, with limited evidence showing efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03520504.