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Zapping brain tumors without zapping memory: new trial for melanoma patients

NCT ID NCT01644591

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

49 people

The number who actually took part.

Started

Aug 2012

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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