NCT01644591Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 17 Jul 2012
- Start date
- 2 Aug 2012
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT01644591
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 49
- From 2 Aug 2012 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months
Other illness
- 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
Lab values
- Female patients of childbearing age are excluded if they are pregnant as determined with a serum beta HCG no greater than 14 days prior to study registration, or breast-feeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy)
Other
- Patients are excluded if they are unable to obtain a magnetic resonance imaging (MRI) scan for any other reason
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.