Zapping brain tumors without zapping memory: new trial for melanoma patients
NCT ID NCT01644591
First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This phase II trial is testing whether a precise, high-dose radiation treatment called stereotactic radiosurgery can control melanoma that has spread to more than three spots in the brain. The study includes 49 patients and also checks whether this approach helps preserve memory and thinking. The goal is to see if this focused radiation can stop tumors from growing while causing less harm to healthy brain tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic radiosurgery (focused radiation)
- What this could lead to
- If it works, this could offer a way to control multiple brain tumors from melanoma while helping patients keep their memory and thinking skills.
- What could go wrong
- This is a small, early-phase trial with only 49 participants, so results may not apply to everyone. The treatment may not control all tumors or prevent memory decline.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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49 people
The number who actually took part.
- Started
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Aug 2012
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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