Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT02107755
Phase
PHASE2
Status
Completed

Conditions

  • Liver Metastases
  • Lung Metastases
  • Recurrent Melanoma
  • Stage IV Melanoma
  • Tumors Metastatic to Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — BIOLOGICAL
    Given IV
  • stereotactic radiosurgery — RADIATION
    Undergo stereotactic radiosurgery
  • laboratory biomarker analysis — OTHER
    Blood and tissue samples will be collected for research purposes.

Study Details

This phase II trial studies the effectiveness of the combination of stereotactic radiation therapy and ipilimumab in patients with metastatic melanoma that has spread to four or fewer sites in the body (oligometastatic). Stereotactic radiation therapy is a type of external beam radiation therapy that uses special equipment to position the patient and precisely give a either a single large dose of radiation therapy to a tumor or several large doses of radiation therapy to a tumor using precision and accuracy that is guided by onboard daily imaging prior to radiation therapy. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some monoclonal antibodies find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic radiosurgery together with ipilimumab may kill more tumor cells by causing addition melanoma antigens to be presented to the immune system.

Key Dates

Start date
Sep 5, 2014
Status verified
Apr 2024
Primary completion
Aug 3, 2020
Completion
Aug 16, 2021

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ipilimumab, stereotactic radiosurgery)
    Patients receive ipilimumab IV over 90 minutes on day 1 in weeks 1, 4, 7, and 10. Treatment repeats every 3 weeks for up to 4 total doses in the absence of disease progression or unacceptable toxicity. At approximately 5-6 weeks, patients undergo stereotactic radiosurgery over 2-3 days per week. Patients with stable disease or confirmed partial or complete response after completion of ipilimumab therapy at week 12 may receive re-induction ipilimumab at the discretion of the treating physician.

Primary Outcome Measure

Rate of Progression-free Survival by mWHO Criteria [ Time Frame: Time of study enrollment until the first documented date of disease progression, assessed up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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