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

NCT01644591 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2011-0875NCI-2018-01809
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Time to progression

  Time to local failure will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of local failure rate in patients treated with stereotactic radiosurgery (SRS) to null hypothesis with respect to the time to local failure. Patients who are lost to follow-up or who die from distant disease before having local failure will be censored. Local control rates at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.

  Up to 12 months

• Time to neurocognitive failure

  The baseline Listening Vocabulary Levels Test-Revised (HVLT-R) score will be compared to the HVLT-R score in patients surviving 4 months. Preservation of function is defined as improvement of HVLT-R score or decline by 4 points or less. Failure is defined as decline by 5 or more points. Time to neurocognitive decline will be estimated using the product-limit estimator of Kaplan and Meier, and log-rank test will be used for comparison of neurocognitive decline rate in patients treated with SRS to null hypothesis with respect to the time to neurocognitive decline. Patients who are lost to follow-up or who die before having neurocognitive decline will be censored. Rates of neurocognitive decline at 4 months may be estimated with 95% confidence intervals using Kaplan-Meier method.

  Up to 12 months

Secondary Outcomes (3)

• Overall survival

  Up to 12 months

• Neurocognitive function score

  Up to 12 months

• Number of cycles of systemic chemotherapy given following radiation treatment

  Up to 12 months

Study Arms (1)

Treatment (SRS)

EXPERIMENTAL

Patients undergo SRS on day 1.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SRS)

Questionnaire Administration OTHER

Ancillary studies

Treatment (SRS)

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Treatment (SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with histologic proof of malignant melanoma. Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc). Cytology-alone is not an acceptable method of diagnosis
• Greater than 3 presumed melanoma brain metastases on contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study registration
• Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
• Patients must have Karnofsky performance status (KPS) \>= 70
• Patients must be eligible to have all lesions treated as determined by the study radiation oncologist
• Creatinine clearance \> 30 ml/min
• Platelets \> 50,000
• Patients should have normal coagulation (international normalized ratio \[INR\] \< 1.3) and be able to withhold anticoagulation/antiplatelet medications a minimum of 24 hours prior to radiosurgery treatment (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery treatment has concluded
• Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist

You may not qualify if:

• Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months
• Patients are excluded if they have a history of metastatic cancer in addition to melanoma or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded
• Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence of leptomeningeal disease
• Patients are excluded if there is any history of gadolinium allergy
• Patients are excluded if they are unable to obtain a magnetic resonance imaging (MRI) scan for any other reason

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Brain Neoplasms; Melanoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jing Li

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: August 2, 2012
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)