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OpenTrials
Completed

NCT Number: NCT03520504

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

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. number of patients with dose-limiting toxicity

    Time frame: 2 years

    will be assessed by physician-graded CTCEAv4

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 9, 2018
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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