SRS (Stereotactic Radiosurgery) Plus Ipilimumab

Conditions

• Newly Diagnosed Melanoma Metastases in the Brain and Spine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Radiosurgery (SRS) — PROCEDURE
• Ipilimumab — BIOLOGICAL

Study Details

This research is being done to look at the safety of using stereotactic radiosurgery (SRS) and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of care uses both of these treatments but not together. By using them together, we expect better treatment of melanoma, but there might be an increase in side effects. "Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer. "Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without needing to cut or use stitches. The use of combining SRS and Ipilimumab in this research study is investigational. The word "investigational" means that this combination is not approved for marketing by the Food and Drug Administration but is allowed for use in this research study.

Key Dates

Start date

Sep 30, 2013

Status verified

Nov 2016

Primary completion

Sep 30, 2016

Study Design

Enrollment

4 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Brain
  A cohort of six (6) patients will be treated at Dosing Schedule 1. If the observed dose limiting toxicity (DLT) rate is less ≤33%, the dose cohort will be expended to a total of 15 patients. Brain and spine metastases will be evaluated as two separate cohorts. If the first schedule produces DLTs in \>33% of patients, the Second Dosing schedule will be implemented. If the second dosing schedule produces DLTs in \>33% of patients, the Third Dosing schedule will be implemented. After 6 patients were enrolled in a cohort, their safety and toxicity will be continuously monitored till 12 weeks (3 months) after the initial dose of Ipilimumab is given for evaluating dose-limiting toxicities.
• Experimental: Spine
  A cohort of six (6) patients will be treated at Dosing Schedule 1. If the observed dose limiting toxicity (DLT) rate is less ≤33%, the dose cohort will be expended to a total of 15 patients. Brain and spine metastases will be evaluated as two separate cohorts. If the first schedule produces DLTs in \>33% of patients, the Second Dosing schedule will be implemented. If the second dosing schedule produces DLTs in \>33% of patients, the Third Dosing schedule will be implemented. After 6 patients were enrolled in a cohort, their safety and toxicity will be continuously monitored till 12 weeks (3 months) after the initial dose of Ipilimumab is given for evaluating dose-limiting toxicities.

Primary Outcome Measure

Number of adverse events and severity of the adverse events. [ Time Frame: 2 years ]

Locations (1)

Find similar trials in Baltimore, MD