NCT01644591

Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases

A Phase II Trial to Determine Local Control and Neurocognitive Preservation After Initial Treatment With Stereotactic Radiosurgery (SRS) for Patients With >3 Melanoma Brain Metastases

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well stereotactic radiosurgery works in treating patients with melanoma that has spread to more than 3 places in the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Detailed description

PRIMARY OBJECTIVES: I. To determine local control of brain metastases at 4 months after initial treatment with stereotactic radiosurgery (SRS) in patients with \> 3 melanoma brain metastases (MBM). II. To determine cognitive decline at 4 months defined as a significant decline (\>= 5 point decrease from baseline based on the reliable change index) in the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall after initial treatment with SRS versus whole brain radiation therapy (WBRT) in patients with \> 3 MBMs. SECONDARY OBJECTIVES: I. To determine local tumor control and distal tumor control in the brain at 1, 4, 6, 9 and 12 months post-treatment. II. To determine overall survival in treated patients. III. To assess the pattern of neurocognitive change in memory at 1, 4, 6, 9, and 12 months post-treatment as well as executive function, attention, processing speed and upper extremity fine motor dexterity. IV. To evaluate composite neurocognitive function scores in treated patients. V. To assess the pre-treatment factors of age, Karnofsky performance scale (KPS), extra-cranial disease, BRAF-V600E mutation status in the predictive determination of local and distal control and neurocognitive outcome in each treatment arm. VI. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome in each treatment arm. VII. To document post-treatment adverse side effects in treated patients. VIII. Evaluate the time to initiation of systemic therapy from completion of radiation treatment. IX. Evaluate the duration/number of cycles of systemic chemotherapy given following radiation treatment. CORRELATIVE STUDIES: I. To determine if apolipoprotein E (Apo E) (i.e., Apo E2, Apo E3, and Apo E4) genotyping may prove to be a predictor of radiation induced neurocognitive decline (or neuro-protection). II. To determine if inflammatory markers (i.e., IL-1, IL-6, and TNF-alpha) may prove to be predictors of radiation induced neurocognitive decline. III. To determine if hormone and growth factors (i.e., glucocorticoids \[e.g., cortisol\], gonadal steroids \[e.g., estradiol, testosterone, progesterone\], growth hormone, human chorionic gonadotropin (hCG), insulin-like growth factor-1 \[IGF-1\], and neuronal growth factor \[NGF\]) may prove to be a predictor of radiation induced neurocognitive decline. IV. To assess whether baseline and post-radiation fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scans can predict for neurocognitive decline. OUTLINE: Patients undergo SRS on day 1. After completion of study treatment, patients are followed up for 12 months.

Conditions

• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Melanoma
• Pathologic Stage IV Cutaneous Melanoma AJCC v8

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Radiosurgery	Undergo SRS

Timeline

• Start date: 2012-08-02
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2012-07-19
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study