Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors

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Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors

Study Purpose

The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy. Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.

- Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases.

- Patients of all ages.

- KPS ≥ 60 for participants ≥ 16 years old, and Lansky ≥ 60 for participants < 16 years old.

- For adult patient, the patient/ legally authorized representative is able to provide informed consent.

For pediatric patient, a parent is able to provide informed consent.

- Adequate bone marrow function: - Hemoglobin > 8g/dL.

- Absolute neutrophil count >1,000/mm.

- Platelet count > 100,000/mm.

- Female subjects must either be of non-reproductive potential (i.e. pediatric patients, OR postmenopausal by history [≥ 60 years old, or with no menses for >1 year without an alternative medical cause], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.

- Patient at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

- Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy.

- Patient with extensive systemic disease and without reasonable systemic treatment options.

- Patient who is unable to undergo MRI brain and spine with gadolinium contrast.

- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.

- Pregnant or lactating women.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04343573
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Divya Yerramilli, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Leptomeningeal Metastases
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Proton CSI Followed by Standard of Care (NSCLC & Breast)

Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Experimental: Standard of Care

Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Other: Proton CSI Followed by Standard of Care (Other Solid Tumors)

(Exploratory arm) Patients with solid tumor malignancies other than NSCLC or breast cancer will be enrolled to the exploratory proton CSI arm (Arm C) and will not undergo randomization. Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.

Interventions

Radiation: - Involved-field Photon Radiation Therapy

Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions)

Radiation: - Proton Craniospinal Irradiation (CSI)

Proton CSI (30Gy [RBE] in 10 fractions)

Other: - Neurocognitive Assessment

All patients at MSKCC will complete a neurocognitive test battery at study entry (prior to RT), and approximately 3, 6 and 12 months and post -RT. The neurocognitive tests consists of standardized, validated and reliable measures of attention, executive functions, and memory, for which age- and education-matched healthy control published data are available. Patients will also complete self-report mood and fatigue scales at each of the same time points. This testing will only be done at MSKCC. Non-English-speaking patients and pediatric patients are exempt from completing the neurocognitive assessments. Neurocognitive assessments will be performed in person at MSK-Manhattan; an option to perform follow up assessments via telehealth will be available only for patients who are not able to go to Manhattan for these visits.

Other: - MDASI-BT and MDASI-SP

Using MDASI-BT and MDASI-SP questionnaires before, weekly during, at 3 months (+/- 4 weeks), 6 months (+/- 4 weeks), 9 months (+/- 4 weeks), and 12 months (+/- 4 weeks) after group assignment, and at CNS disease progression. Only one set needs to be completed. Non-English-speaking patients and pediatric patients are exempt from completing the patient-reported outcomes unless translated PRO assessment forms are available. Questionnaires will be completed via mail, in-person, or online (MSK Engage).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Middletown, New Jersey

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Memorial Sloan Kettering Monmouth (Limitedl protocol activities)

Middletown, New Jersey, 07748

Montvale, New Jersey

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Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Commack, New York

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Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725

Harrison, New York

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Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Memorial Sloan Kettering Cancer Center, New York, New York

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Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Uniondale, New York

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Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

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