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

Leptomeningeal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520504
• Other study ID #: 18-205
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: December 22, 2022

Study information

• Verified date: December 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: >/= 60 years old and 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 with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.

• KPS = 60.

• Age = 10 years.

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

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

• Adequate bone marrow function:

• Hemoglobin = 8g/dL

• Absolute neutrophil count =500/mm^3

• Platelet count = 100,000/mm^3

Exclusion Criteria:

• Patient with multiple, serious major neurologic deficits 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.

Related Conditions & MeSH terms

• Leptomeningeal Metastases
• Meningeal Carcinomatosis
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with dose-limiting toxicity	will be assessed by physician-graded CTCEAv4	2 years

External Links

•   Memorial Sloan Kettering Cancer Center