Evaluating 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

This study is testing how a specific type of radiation treatment affects thinking and memory in people with brain metastases.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT03508752 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effects of stereotactic radiosurgery on neurocognitive function in patients with brain metastases. The study is divided into two phases: the first phase focuses on determining the maximum tolerated dose (MTD) of the treatment, while the second phase evaluates changes in neurocognitive function using the Hopkins Verbal Learning Test-Revised. A total of 50 patients will be enrolled in the second phase after establishing the MTD, with a study duration of three years. The trial builds on previous findings regarding the impact of treatment on cognitive outcomes in patients with multiple brain metastases.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with six or more brain metastases and a performance status of ECOG 2 or better.

Not a fit: Patients with prior stereotactic radiosurgery to the lesions being treated or those with germ cell cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive outcomes for patients undergoing treatment for brain metastases.

How similar studies have performed: Previous studies have shown varying success with similar approaches, indicating a need for further investigation in this area.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. ECOG Performance Score of 2 or better/Karnofsky Performance score of 50-60 or better.
3. Biopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study.
4. 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.
5. Largest tumor \<= 4 cm.
6. No prior SRS to the lesions which will be treated on protocol.
7. 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).
8. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Prior whole brain radiotherapy
2. 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.)
3. Patients with life expectancy \< 4 months.
4. Psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
5. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Zabi Wardak, MD — UT Southwestern Medical Center
• Study coordinator: Christian Chukwuma

Conditions Brain Metastases