MeDex: No Perioperative Dexamethasone in Brain Metastases

Study Purpose

Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. New brain tumor(s) on imaging. 2. Visceral mass(es) suspicious for neoplasm. a. Patients with lung mass suspicious for primary lung cancer and no prior diagnosis must undergo biopsy of the lung mass prior to resection of brain metastasis(es) to exclude histology (i.e., small cell lung carcinoma) that would not benefit from resection. 3. No contraindications for craniotomy. 4. Age ≥ 18 years. 5. ECOG performance status ≤ 2 (i.e., ambulatory > 50% of waking hours) 6. Midline shift on MRI ≤ 10 mm. 7. Craniotomy planned to resect >75% of the enhancing mass (surgeon's judgment)

Exclusion Criteria:

1. Presence of BMs not eligible for resection that are each > 2 cm in any one dimension. 2. >4 BMs not eligible for resection that are each 2 cm in any one dimension. 3. Treatment with laser interstitial thermal therapy (LITT) 4. High concern for primary CNS lymphoma. 5. Diagnosis of small cell lung carcinoma. 6. Any receipt of Dex. 7. Steroid use in the past month. 8. A condition that requires steroids. 9. Stage 4 chronic kidney disease (GFR<30) 10. Pregnant or breastfeeding

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07044557
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Louisville
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Additional Details

This is a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex in a maximum of 35 patients screened and enrolled in our emergency room and clinics. We will assess efficacy by noting presence of absence of lymphopenia. The patients will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.

Arms & Interventions

Arms

Experimental: Withholding perioperative dexamethasone

The safety and feasibility of withholding perioperative dexamethasone (Dex) in newly diagnosed cancer patients undergoing resection of brain metastases (BMs). The primary question is not comparative efficacy, but rather whether it is safe to forgo Dex in this patient population.

Interventions

Other: - Withholding perioperative Dexamethasone

Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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