Testing a new radiation therapy for brain metastases
Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases
PHASE1 · Albert Einstein College of Medicine · NCT03726359
This study is testing a new type of radiation therapy for people with brain metastases to see how safe it is and what the best dose might be.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine (other) |
| Drugs / interventions | chemotherapy, immunotherapy, Radiation |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT03726359 on ClinicalTrials.gov |
What this trial studies
This Phase I study aims to evaluate the safety and feasibility of Fractionated Stereotactic Radiation Therapy (FSRT) in patients with brain metastases. The study will determine the maximum tolerated dose (MTD) of FSRT, which has not been previously established in prospective trials. Patients with intact or surgically resected brain metastases will receive varying doses of FSRT, and the results will inform future Phase II/III studies on the efficacy of different dose fractionation schedules. The study addresses a significant gap in the current treatment guidelines for brain metastases.
Who should consider this trial
Good fit: Ideal candidates include adults with a pathologically proven non-hematological malignancy and intact brain metastases measuring between 3 cm and 6 cm.
Not a fit: Patients with small cell lung cancer or those with brain metastases outside the specified size range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients with brain metastases.
How similar studies have performed: While there is limited prospective data on FSRT for brain metastases, this approach is novel and aims to fill a significant gap in existing treatment protocols.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration * Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension * Prior Whole Brain Radiation Therapy (WBRT) is allowed * Age ≥ 18 years * Women of childbearing potential and male participants must practice adequate contraception * History/Physical examination within 30 days prior to registration * Life expectancy \>3 months * Patients are allowed to enroll if previously treated to other lesions with Stereotactic Radiosurgery (SRS) * Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints Exclusion Criteria: * Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination * Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment * Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed * Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy * Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity * Previous treatment of the target lesion with radiotherapy
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Madhur Garg, MD — Montefiore Medical Center
- Study coordinator: Nitin Ohri, MD
- Email: nitin.ohri@einsteinmed.edu
- Phone: 718-920-4140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases