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Stereotactic Body Radiation Therapy and Ipilimumab in Treating Patients With Stage IV Melanoma

Complete title: RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma

Research Study Number       9031
Principal Investigator       Ramesh Rengan
Phase       II

Look up trial at NIH

Research Study Description

This phase II trial studies the side effects of stereotactic body irradiation (SBRT) and to see how well it works when given together with ipilimumab in treating patients with stage IV melanoma. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. 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. Giving SBRT with ipilimumab may be effective in treating melanoma.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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 or 1

- 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)

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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 or history of central nervous system metastasis (including brain)

- Long-term use of systemic corticosteroids

- Prior radiation therapy (RT) that precludes the delivery of SBRT

Other exclusion criteria may apply.

Research Study Number       9031
Contact       Jennifer Revall, BA
Telephone       206/667-8629

Melanoma; Skin Cancer; Solid Tumors

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