NCT03520504

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

Completed Phase 1 Last updated 23 December 2022

What this trial tests

Phase 1 trial testing Proton craniospinal irradiation (CSI) in Leptomeningeal Metastases in 24 participants. Completed in 22 December 2022.

Timeline

26 April 2018

Primary endpoint
22 December 2022

22 December 2022

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	26 April 2018
Primary completion	22 December 2022
Estimated completion	22 December 2022
Sites	8 locations across United States

Drugs / interventions tested

• Proton craniospinal irradiation (CSI)

Conditions studied

• Leptomeningeal Metastases — all drugs for Leptomeningeal Metastases →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

10 and older, any sex, with Leptomeningeal Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trial of proton craniospinal irradiation for leptomeningeal metastases.
   Yang TJ, Wijetunga NA, Yamada J, Wolden S, et al · · 2021 · cited 78× · PMID 32592583 · DOI 10.1093/neuonc/noaa152
2. Radiotherapy in Leptomeningeal Disease: A Systematic Review of Randomized and Non-randomized Trials.
   Buszek SM, Chung C. · · 2019 · cited 43× · PMID 31803614 · DOI 10.3389/fonc.2019.01224
3. Leptomeningeal disease in melanoma patients: An update to treatment, challenges, and future directions.
   Glitza IC, Smalley KSM, Brastianos PK, Davies MA, et al · · 2020 · cited 34× · PMID 31916400 · DOI 10.1111/pcmr.12861
4. Quantitative cerebrospinal fluid circulating tumor cells are a potential biomarker of response for proton craniospinal irradiation for leptomeningeal metastasis.
   Wijetunga NA, Boire A, Young RJ, Yamada Y, et al · · 2021 · cited 24× · PMID 34993483 · DOI 10.1093/noajnl/vdab181
5. Dynamic Mutational Landscape of Cerebrospinal Fluid Circulating Tumor DNA and Predictors of Survival after Proton Craniospinal Irradiation for Leptomeningeal Metastases.
   Wijetunga NA, Goglia AG, Weinhold N, Berger MF, et al · · 2023 · cited 15× · PMID 36449664 · DOI 10.1158/1078-0432.ccr-22-2434
6. Metastatic brain tumors: from development to cutting-edge treatment.
   Tanzhu G, Chen L, Ning J, Xue W, et al · · 2025 · cited 8× · PMID 39712454 · DOI 10.1002/mco2.70020
7. Radiotherapy for Leptomeningeal Carcinomatosis in Breast Cancer Patients: A Narrative Review.
   Pawłowska E, Romanowska A, Jassem J. · · 2022 · cited 5× · PMID 36010893 · DOI 10.3390/cancers14163899
8. Long-Term Outcomes of a Prospective Clinical Trial of Proton Craniospinal Irradiation for Leptomeningeal Metastasis.
   Yang JT, Wijetunga NA, Yamada Y, Wolden SL, et al · · 2021 · PMID 34700517 · DOI 10.1016/j.ijrobp.2021.07.084