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

NCT03520504 | Completed Phase 1 FDA Device

• 1 other identifier: 18-205
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Leptomeningeal Metastases

Keywords

Proton Radiation; craniospinal irradiation (CSI); 18-205

Outcome Measures

Primary Outcomes (1)

• number of patients with dose-limiting toxicity

  will be assessed by physician-graded CTCEAv4

  2 years

Study Arms (1)

Proton Radiation

EXPERIMENTAL

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.

Radiation: Proton craniospinal irradiation (CSI)

Interventions

Proton craniospinal irradiation (CSI) RADIATION

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

Proton Radiation

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Daniel Higginson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: April 26, 2018
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

US (8)