Treatment for recurrent brain metastases after radiation therapy

REMASTer: REcurrent Brain Metastases After SRS Trial

This study is testing whether Laser Interstitial Thermal Therapy or other radiation treatments work better for patients with brain tumors that have come back after previous radiation therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 261 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Monteris Medical (Industry-sponsored)
• Drugs / interventions: bevacizumab, radiation
• Locations: 9 sites (Los Angeles, California and 8 other locations)
• Trial ID: NCT05124912 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of two treatment algorithms for patients with recurrent brain metastases following stereotactic radiosurgery (SRS). Participants will receive either Laser Interstitial Thermal Therapy (LITT) or other radiation therapies, with the goal of assessing which approach yields better outcomes. The study focuses on patients whose brain lesions have shown significant growth after initial treatment. It is a randomized, multi-center trial designed to provide insights into optimal management strategies for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are patients with confirmed recurrent brain metastases who have previously undergone SRS and have measurable lesions.

Not a fit: Patients with non-targetable lesions or those who have not previously received SRS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options and outcomes for patients with recurrent brain metastases.

How similar studies have performed: Other studies have shown promise with similar laser therapy approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Patients with radiographically proven (by gadolinium-enhanced \[Gd-\] MRI) parenchymal brain metastases from histologically confirmed non-central nervous system (CNS) cancer.
2. Patients with a "targetable", bidimensionally-measurable, intracranial lesion that is radiographically recurrent after previous treatment with SRS +/- surgery (craniotomy or LITT). To classify a lesion as radiographically progressive, the lesion must demonstrate a ≥ 25% increase in size following treatment based on the Neuro-Oncology Criteria of Tumor Response for CNS Tumors. To be "targetable" for this study, the lesion should be coverable through a planned single LITT trajectory and thus have a maximum perpendicular diameter (perpendicular to the laser trajectory) of 3 cm. An intra-operative decision to utilize two trajectories is acceptable and patient may remain on study.
3. Patient must be at least 3 months post initial SRS treatment of the target lesion
4. Target lesion must be amenable to undergo surgical biopsy and LITT treatment as determined by the treating neurosurgeon.
5. Frozen pathology diagnosis must be attainable.
6. Patient must be symptomatically stable for a minimum of 3 days prior to the procedure date on a on a max total daily steroid dose equivalent to 4mg of Dexamethasone.
7. ≥18 years of age
8. KPS ≥70
9. Patient is able and willing to complete study requirements
10. Patients with adequate hematologic parameters (all tests to be performed within \<4 weeks of biopsy):

    1. ANC ≥ 1.5 X 109/L
    2. Platelet count ≥ 100 x 109/L
11. Blood chemistry laboratory value for serum creatinine \< 1.5 x ULN (test to be performed within \<4 weeks of biopsy)
12. Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)
13. All patients of reproductive potential must agree to use an effective method of contraception during the study
14. Patients must be accessible for follow-up

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients with greater than 3 progressing lesions at time of enrollment. To classify as a radiographically progressive, lesion must demonstrate a ≥ 25% increase in size following treatment based on the RANO criteria. Of note, there is no exclusion for total number of metastases. However, only one lesion can be selected to be the targeted lesion and this lesion alone may be ablated during the study procedure.
2. Patients with concomitant newly diagnosed intracranial metastases (concurrent with the targetable radiographically progressive lesion), as these will require prioritized and different treatment approaches.
3. Prior bevacizumab use within 4 weeks of study initiation
4. Patients with additional concurrent malignancies requiring active treatment, except non-melanoma skin cancer, or in-situ cancer of the cervix
5. Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol related QOL questionnaires and cognition assessments
6. Inability to tolerate or contraindication to steroid therapy (i.e., dexamethasone)
7. Deemed ineligible or unable to tolerate SRS therapy by treating neurosurgeon and/or radiation oncologist
8. Patients with any condition that would prohibit them from undergoing a surgical procedure, at the discretion of the treating physician team
9. Patients unwilling or unable to give consent for participation
10. Patients unable to comply with study requirements
11. Patients with diffuse leptomeningeal disease
12. Patients with rapidly progressing extracranial disease

Where this trial is running

Los Angeles, California and 8 other locations

• UCLA — Los Angeles, California, United States (Recruiting)
• University of Chicago — Chicago, Illinois, United States (Recruiting)
• University of Maryland — Baltimore, Maryland, United States (Recruiting)
• WashU — St Louis, Missouri, United States (Recruiting)
• Duke University Hospital — Durham, North Carolina, United States (Active_not_recruiting)
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Kettering Health — Kettering, Ohio, United States (Recruiting)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Peter Fecci, MD — University of Colorado, Denver
• Study coordinator: Christa Seligman

Conditions Brain Metastases; Radiation Necrosis; Recurrent Tumor; Recurrent Metastases; Laser Interstitial Thermal Therapy; Stereotactic Radiosurgry; LITT; SRS