Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

Stopped early · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Skin Melanoma

In brief

This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.

Key facts

Study ID

NCT01970527

Run by

University of Washington

People needed

23

Starts

2014-03-01

Expected to finish

2019-06-21

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of melanoma
• Previously treated or previously untreated stage IV melanoma by American Joint Committee on Cancer (AJCC) staging criteria
• Presence of an index lesion between 1 and 5 cm
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Signed informed consent document
• Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
• Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)

You may not qualify if…

• Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
• Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
• Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active
• Long-term use of systemic corticosteroids; patients with replacement steroids and not immunosuppressive steroids may enroll in the study
• Prior radiation therapy (RT) that precludes the delivery of SBRT

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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