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

Primary Purpose

Leptomeningeal Metastases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton craniospinal irradiation (CSI)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leptomeningeal Metastases focused on measuring Proton Radiation, craniospinal irradiation (CSI), 18-205

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

number of patients with dose-limiting toxicity
will be assessed by physician-graded CTCEAv4

Secondary Outcome Measures

Full Information

First Posted
April 27, 2018
Last Updated
December 22, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03520504
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leptomeningeal Metastases
Keywords
Proton Radiation, craniospinal irradiation (CSI), 18-205

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, prospective trial with 3+3 dose de-escalation and dose expansion cohort.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Proton craniospinal irradiation (CSI)
Intervention Description
Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.
Primary Outcome Measure Information:
Title
number of patients with dose-limiting toxicity
Description
will be assessed by physician-graded CTCEAv4
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Higginson, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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