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RecruitingPhase 1Phase 2NCT03508752

Neurocognitive Decline in Patients With Brain Metastases

Phase I/II Trial to Determine the Neurocognitive Decline in Patients With Multiple (>6) Brain Metastases Treated With Distributed Stereotactic Radiosurgery

Sponsor

University of Texas Southwestern Medical Center

Enrollment

80 participants

Start Date

Dec 5, 2017

Study Type

INTERVENTIONAL

Conditions

Brain Metastases

Summary

The phase I component of the study is to identify maximal tolerated dose (MTD). The phase II is to evaluate neurocognitive decline.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • Age ≥ 18 years.
  • ECOG Performance Score of 2 or better/Karnofsky Performance score of 50-60 or better.
  • Biopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study.
  • Six or more metastases on diagnostic or treatment planning imaging, which include either CT Brain (with contrast) or MR Brain (with or without contrast) imaging.
  • Largest tumor <= 4 cm.
  • No prior SRS to the lesions which will be treated on protocol.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria5

  • Prior whole brain radiotherapy
  • Patients with leptomeningeal metastasis. (NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.)
  • Patients with life expectancy < 4 months.
  • Psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

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Interventions

RADIATIONStereotactic Radiosurgery

Stereotactic Radiosurgery dose is based on the largest tumor size

Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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