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Radiation Therapy

Stereotactic Radiosurgery for Melanoma Brain Metastases

Phase 2
Waitlist Available
Led By Jing Li
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months
Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence of leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well stereotactic radiosurgery works to treat patients with melanoma that has spread to the brain.

Who is the study for?
This trial is for melanoma patients with more than three brain metastases confirmed by MRI. They must have normal kidney function, blood platelet count, and coagulation levels; be able to pause certain medications around treatment time; and not be pregnant or breastfeeding. Patients previously treated with whole-brain radiotherapy or those with additional cancers are excluded.
What is being tested?
The study tests stereotactic radiosurgery's effectiveness on patients with multiple melanoma brain metastases. This precise radiation therapy targets tumors directly in a single high dose, potentially sparing healthy tissue.
What are the potential side effects?
Stereotactic radiosurgery may cause headaches, fatigue, nausea, hair loss at the treatment site, swelling in the brain which can lead to neurological issues, and very rarely seizures or hemorrhage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma diagnosis was confirmed through tissue examination.
Select...
I have more than 3 melanoma brain tumors as shown in my recent MRI.
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My blood clotting is normal and I can stop blood thinners for radiosurgery.
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I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had whole brain radiotherapy in the last 3 months.
Select...
I do not have cancer spread to the lining of my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to neurocognitive failure
Time to progression
Secondary study objectives
Neurocognitive function score
Number of cycles of systemic chemotherapy given following radiation treatment
Overall survival

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702
32%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Urinary tract pain
8%
Watering eyes
8%
Weight loss
8%
Myalgia
8%
Wheezing
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Upper respiratory infection
4%
Vomiting
4%
Urinary tract infection
4%
White blood cell decreased
4%
Lethargy
4%
Sore throat
4%
Skin infection
4%
Urinary urgency
4%
Insomnia
4%
Infusion site extravasation
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SRS)Experimental Treatment3 Interventions
Patients undergo SRS on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,298 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,038 Total Patients Enrolled
Jing LiPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
51,683 Total Patients Enrolled

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01644591 — Phase 2
Brain Metastasis Research Study Groups: Treatment (SRS)
Brain Metastasis Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT01644591 — Phase 2
Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01644591 — Phase 2
~6 spots leftby Aug 2026
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