Clinical trial NCT03520504: Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases
Official title: A Phase Ib Study With Dose Expansion Cohort of Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leptomeningeal Metastases
Keywords: Proton Radiation
craniospinal irradiation (CSI)
18-205
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, prospective trial with 3+3 dose de-escalation and dose expansion cohort.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of patients with dose-limiting toxicity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Higginson, MD
role: PRINCIPAL_INVESTIGATOR
References: