Analyses of Metabolic Agents Following Brain Radiation

Overview

Información sobre este estudio

The purpose of this study is to determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Radiographic evidence or histopathologic confirmation of CNS malignancy, with or without prior resection.  .
  • Planned (cohort 1) or completed (cohort 2) fractionated brain radiation. The therapeutic brain radiation treatment volume should exceed 30 cubic cm, including the volume of brain tissue occupied by infiltrative disease. Volume occupied by solid non-infiltrative disease (e.g., meningioma, metastatic disease, cystic cavity, resection cavity), should be excluded from the estimated treatment volume.
  • Provide written informed consent for the current study and the Neuro-oncology biorepository for archiving of CSF and blood samples collected on this protocol.
  • Expected survival >6 months and Karnofsky performance status ≥ 60.
  • Willing and able to adhere with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations.
  • The following laboratory values obtained ≤14 days prior to registration:
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) < 3 x ULN (≤ 5 x ULN for patients with baseline liver disease);
    • Serum creatinine ≤ 1.5 mg/dL.
  • Willingness to provide mandatory CSF and blood and able to undergo MRS/MRI with gadolinium.
  • Male and female patients of childbearing potential must agree to use a dual method of contraception (a highly effective method of contraception in conjunction with barrier contraception) consistently and correctly from the first dose of study drug (Arm B only) until 90 days after the last dose of study drug.
  • Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion Criteria:

  • Uncontrolled and/or intercurrent illness which limits safety of or compliance to study proceedings.
  • Vulnerable populations: pregnant or nursing women (Arm B exempt), prisoners, mentally handicapped.
  • Patients with recurrent brain tumor after prior radiation.
  • Cohort 1 only: History of prior brain radiation, with prior cumulative target radiation treatment volume exceeding 2 cubic centimeters.
  • Patients who do not have an implanted CSF access device (who would thus require multiple LPs for participation) should be excluded if they have any contra-indication to lumbar puncture. This includes but is not limited to Age ≥ 18 years.
  • Radiographic evidence or histopathologic confirmation of CNS malignancy, with or without prior resection.  
  • Planned (cohort 1) or completed (cohort 2) fractionated brain radiation. The therapeutic brain radiation treatment volume should exceed 30 cubic cm, including the volume of brain tissue occupied by infiltrative disease. Volume occupied by solid non-infiltrative disease (e.g., meningioma, metastatic disease, cystic cavity, resection cavity), should be excluded from the estimated treatment volume.
  • Provide written informed consent for the current study and the Neuro-oncology biorepository for archiving of CSF and blood samples collected on this protocol.
  • Expected survival > 6 months and Karnofsky performance status ≥ 60.
  • Willing and able to adhere with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations.    The following laboratory values obtained ≤ 14 days prior to registration:
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) < 3 x ULN (≤ 5 x ULN for patients with baseline liver disease).
  • Serum creatinine ≤ 1.5 mg/dL.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Wllingness to provide mandatory CSF and blood and able to undergo MRS/MRI with gadolinium.
  • Male and female patients of childbearing potential must agree to use a dual method of contraception (a highly effective method of contraception in conjunction with barrier contraception) consistently and correctly from the first dose of study drug (Arm B only) until 90 days after the last dose of study drug.

Eligibility last updated 4/5/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Terence Burns, M.D., Ph.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

William Winter

(507) 422-5673

Winter.William@mayo.edu

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales