Brain Metastases
Conditions
Brief summary
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Detailed description
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. Investigators 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.
Interventions
OTHERWithholding perioperative Dexamethasone
Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone. We will conduct a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex. We will assess efficacy by noting presence of absence of lymphopenia. The participants will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. New brain tumor(s) on imaging 2. Visceral mass(es) suspicious or confirmed 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dexamethasone Rescue Need | 4 weeks post operative (+-) 2 weeks | Initiation of dexamethasone after enrollment up to 3 weeks after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunosuppression Assessment | 4 weeks post operative (+-) 2 weeks | Presence of absence of lymphopenia prior to adjuvant cancer therapy. |
Countries
United States
Contacts
CONTACTA Mistry, MD
CONTACTM Kaufman, BSN
PRINCIPAL_INVESTIGATORAkshitkumar Mistry, MD
University of Louisville
Outcome results
None listed