Overview

Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery

Status:
Terminated
Trial end date:
2020-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is a study to test the efficacy of using standard immune therapy for melanoma prior to stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as or better than controlling brain metastases as compared to stereotactic radiosurgery followed by immune therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan Cancer Center
University of Michigan Rogel Cancer Center
Treatments:
Antibodies, Monoclonal
Ipilimumab
Criteria
Inclusion Criteria:

- Patients with a histologically-confirmed diagnosis of melanoma who have imaging
findings suggestive of 1 to 4 brain metastases

- At least one lesion in the brain that is measurable, which is defined as ≥5 x 5mm
(Prior craniotomy and surgical resection is allowed, as long as there is at least one
remaining measurable lesion in the brain)

- Patients must be candidates for stereotactic radiosurgery (SRS) and planning to
undergo SRS

- Patients must be candidates for ipilimumab as determined by the treating physician

- Patients must be neurologically asymptomatic, or very minimally symptomatic, as judged
by the treating physicians

- At least 3 weeks has elapsed from any prior therapy, and the patient has recovered
from side effects to ≤ grade 1 toxicities per Common Terminology Criteria (CTC) for
Adverse Events

- Age > or = 18 years old

- Performance status of ECOG of 0 or 1 (ECOG is the Eastern Oncology Cooperative Group
Scoring system used to quantify cancer patients' general well-being and activities of
daily life; scores range from 0 to 5 where 0 is perfect health and 5 is death)

- Adequate organ and marrow function: alanine aminotransferase (ALT ) < 2.5x's upper
limit of normal (ULN) of the institutional normal reference range, aspartate
aminotransferase (AST) < 2.5x's ULN of the institutional normal reference range,
Bilirubin < 1.5x's ULN of the institutional normal reference range, Creatinine < 2.0
milligrams per deciliter, Platelets > 50,000 per microliter

- Women of child-bearing potential must agree to use adequate contraception, defined as
complete abstinence from intercourse with men or two methods

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Previous radiotherapy to the lesion(s) of interest, including prior treatment with
whole brain radiation therapy (WBRT). Prior treatment with SRS is allowed if the index
lesion(s) is in a different, non-contiguous location than the previously treated
lesion.

- Patients who have previously received ipilimumab, PD-1 inhibitors or PD-L1 inhibitors
are excluded due to the potential of effects on primary outcome

- Patients who require WBRT or surgery at the time of enrollment

- Neurologic symptoms or imaging findings that necessitate the use of steroids on the
day of enrollment or in the prior 7 days

- Highly suspicious magnetic resonance imaging (MRI) or cerebrospinal fluid evidence of
leptomeningeal metastases, unless all measurable disease is localized and SRS is
considered the treatment of choice

- Concurrent treatment with any other anti-neoplastic drug or concurrent participation
in another therapeutic clinical trial

- Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker,
implanted cardiac defibrillator, aneurysm clips, history of allergic
reaction/hypersensitivity to gadolinium)

- Women who are pregnant or are nursing

- Patients with absolute lymphocyte count of <500 cells/microliter, who are known to be
HIV positive, who have clinically significant active autoimmune disease, or are
receiving immunosuppression following solid organ or stem cell transplant