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

University of Washington

Status and phase: Terminated; Phase 2

Conditions: Stage IV Skin Melanoma; Recurrent Melanoma

Treatments: Other: Laboratory Biomarker Analysis; Radiation: Stereotactic Body Radiation Therapy; Biological: Ipilimumab; Other: Pharmacological Study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01970527

P30CA015704 (U.S. NIH Grant/Contract)

9031

NCI-2013-01757 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine feasibility and immune-related clinical responses associated with SBRT when given in conjunction with ipilimumab.

SECONDARY OBJECTIVES:

I. To determine late toxicity and immune pharmacodynamic changes after SBRT followed by ipilimumab.

OUTLINE:

Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab intravenously (IV) every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 60 days, and then every effort will be made to obtain records of patients during this follow up, and permission will be sought for the investigators and/or study team to re-contact the patient directly with regard to health status and toxicity.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Treatment (stereotactic body radiotherapy, ipilimumab)

Experimental group

Description:

Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab IV every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: Pharmacological Study

Biological: Ipilimumab

Other: Laboratory Biomarker Analysis

Radiation: Stereotactic Body Radiation Therapy