NCT02390518 Stereotactic Radiosurgery Dose Escalation for Brain Metastases
| NCT ID | NCT02390518 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Utah |
| Condition | Brain Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2015-05-07 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 86 participants in total. It began in 2015-05-07 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase I dose escalation and expansion trial. The purpose of this study is to determine the maximum tolerated dose of radiation received during stereotactic radiosurgery in patients with brain metastases who have never received radiation to the brain before.
Eligibility Criteria
Inclusion Criteria: * Clinically confirmed brain metastases by CT or MRI criteria. If there is evidence of extra-cranial metastatic disease, it is preferable that the lesions be pathologically confirmed (see section 4.2.5 for excluded histologies) and reviewed by a University of Utah or Huntsman Cancer Hospital pathologist if the initial review was done at an outside facility. * Prior brain surgery is allowed, although a lesion situated in the operative bed would not be selected to receive an experimental dose of SRS treatment. SRS should be delivered 4-6 weeks post-surgery if the patient had a craniotomy for resection of a lesion. Enrollment of a patient with the goal of performing SRS outside of the 4-6 post-craniotomy window is at the PI's discretion. * Patients must have 1-5 untreated brain metastases total. * For patients planning to enroll in Cohort 1a (including expansion) or Cohort 1b: Tumor volume ≤ 4.1888 cm3 by CT or MRI measurement at the time of consultation/screening for the metastatic lesion on trial. Patients who have at least one additional lesion that is larger than the lesions eligible for the expansion cohort, but who are unable to find another open cohort, will have the eligible lesion(s) treated in the expansion cohort, and the remaining lesion(s) treated at the standard dose. * For patients enrolling in the expansion Cohort 1a: Up to five brain metastases with tumor volume ≤ 0.5237 cm3 by CT or MRI measurement at the time of consultation/screening will be treated on trial with the MTD. Brain metastases with volume \> 0.5237 cm3 will be treated by standard of care SRS dosing. * For patients enrolling in Cohort 1b: Tumor volume of \> 0.5237 cm3 and ≤ 4.1888 cm3 by CT or MRI measurement at the time of consultation/screening for the metastatic lesion on trial. All other brain metastases will be treated by standard of care SRS dosing. * As of Protocol Version 9, Cohorts 2 and 3 are permanently closed to accrual. For patients planning to enroll in Cohort 2 or 3: Equivalent tumor diameter ≤ 40 mm by CT or MRI measurement at the time of consultation/screening for the metastatic lesion on trial. Equivalent tumor diameter \</=40 mm by CT or MRI measurement for all lesions treated by standard of care SRS dosing. * All metastatic lesions must be separated by a minimum of 3 cm as measured from the peripheral edges of the lesions that are in closest proximity to one another. If multiple lesions are present and are not all ≥ 3 cm away from each other, the patient will be deemed ineligible. * Prior systemic therapy is allowed, although appropriate washout is required for patients who have been on BRAF inhibitors (at least 7 days). * For subjects currently on active systemic cancer therapy, the treating medical oncologist should be consulted to ensure proper washout (if appropriate) periods prior to SRS. * Patients must be at least 18 years of age. * Karnofsky Performance Status (KPS) ≥ 60. * Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines. * Women of child-bearing potential must have a negative pregnancy test within 10 days of study enrollment and must agree to use an acceptable method of birth control while receiving radiation and for 3 months after radiation. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \>1 year. * Men who are able to father a child must agree to use an acceptable method of birth control while receiving radiation, and for 3 months after radiation. Exclusion Criteria: * Prior whole brain irradiation. * Brain lesions with an equivalent diameter of \> 40 mm in size on MRI imaging at the time of consultation/screening for protocol eligibility. * Lesions located in anatomic regions that are not amendable to SRS (e.g., optic nerve) * Brain lesions located in the brain stem. * Radiographic or cytologic evidence of leptomeningeal disease * Primary lesion with radiosensitive histology that includes the following: small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma * Women of child-bearing potential who are pregnant or breast feeding * Patients with multiple lesions, which by size criteria would be enrolled in a cohort that is full at the time of enrollment and the 12-16 weeks DLT period has not yet been reached.
Contact & Investigator
Lindsay Burt, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute
Frequently Asked Questions
Who can join the NCT02390518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02390518 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02390518 currently recruiting?
Yes, NCT02390518 is actively recruiting participants. Contact the research team at David.Ostler@hci.utah.edu for enrollment information.
Where is the NCT02390518 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT02390518 clinical trial?
NCT02390518 is sponsored by University of Utah. The principal investigator is Lindsay Burt, MD at Huntsman Cancer Institute. The trial plans to enroll 86 participants.