Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT01703507
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Tumors Metastatic to Brain

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Given IV
  • Whole-Brain Radiation Therapy (WBRT) — RADIATION
    Undergo WBRT
  • Stereotactic Radiosurgery (SRS) — RADIATION
    Undergo SRS

Study Details

This phase I trial studies the side effects and best dose of ipilimumab when given together with whole brain radiation therapy or stereotactic radiosurgery in treating patients with melanoma with brain metastases. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find Tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy, such uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving ipilimumab together with whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor cells.

Key Dates

Start date
Nov 9, 2012
Status verified
May 2025
Primary completion
May 20, 2015
Completion
Apr 11, 2018

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Ipilimumab and Whole Brain Radiation Therapy)
    Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.
  • Experimental: Arm B (Ipilimumab and Stereotactic Radiosurgery)
    Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Ipilimumab [ Time Frame: 30 days following the completion of radiation therapy ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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By research site
Ohio State University· Columbus, OHThomas Jefferson University· Philadelphia, PA

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