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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|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Sexes Eligible for Study: All
- 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)
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active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
Other exclusion criteria may apply.
Melanoma; Skin Cancer; Solid Tumors; Neoplasms, Germ Cell and Embryonal; Neuroendocrine Tumor; Neoplasms; Neuroectodermal Tumors; Neoplasms, Nerve Tissue; Immunotherapy
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