A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients With Advanced Melanoma
This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : sargramostim
- biological : ipilimumab
Phase: Phase 2
Ages Eligible For Study:
- Histologically confirmed metastatic melanoma - Unresectable stage III or IV disease - For unknown primary disease, diagnosis of metastatic disease by cytology FNA is not acceptable - Measurable disease - ECOG performance status 0-1 - White blood count (WBC) ? 2,000/?L - Absolute neutrophil count (ANC) ? 1,500/mcL - Platelet count ? 100,000/mcL - Hemoglobin ? 8 g/dL - Creatinine ? 3.0 times upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 times ULN - Bilirubin ? 3.0 times ULN (total bilirubin < 3.0 mg/dL for patients with Gilbert syndrome) - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 12 weeks after completion of study - Patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy - At least 4 weeks since prior and no concurrent therapy with any of the following: - Aldesleukin (IL-2) - Interferon - Non-study immunotherapy regimens - Cytotoxic chemotherapy - Immunosuppressive agents - Other investigational therapies - Chronic use of systemic corticosteroids - Concurrent inhaled or topical steroids allowed - Concurrent physiologic replacement doses of corticosteroids allowed