Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable stage III or IV melanoma from a cutaneous, mucosal, or unknown primary site Unresectable stage III disease, defined as meeting 1 of the following criteria: Regional metastasis that, in the judgement of the treating physician, cannot be surgically resected with clear margins Regional metastasis that can be surgically resected with clear margins only by extensive surgery that is inadvisable or unacceptable to the treating physician and/or patient Staging of cutaneous and mucosal melanoma based on the revised American Joint Committee on Cancer (AJCC) staging system Must have measurable disease as defined by Response Evaluation Criteria in Small Tumors (RECIST) criteria No ocular melanoma Patients with brain metastases may be eligible if all of the following are true: Total number of brain metastases ever is ≤ 3 Each brain metastasis has been completely removed by surgery or each unresected brain metastasis has been treated with stereotactic radiosurgery Stereotactic radiosurgery, such as gamma knife, can be used up to 1 week before study entry No evident growth of any brain metastasis since treatment No brain metastasis that is > 2 cm in diameter at study entry PATIENT CHARACTERISTICS: ECOG performance status 0-1 Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 9 g/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin normal Creatinine ≤ 1.5 times ULN No New York Heart Association class III or IV heart disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No previous or concurrent autoimmune disorder requiring cytotoxic or immunosuppressive therapy No autoimmune disorder with visceral involvement The following conditions are allowed: Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms Clinical evidence of vitiligo Other forms of depigmenting illness Mild arthritis requiring steroidal anti-inflammatory drugs HIV negative Hepatitis C negative No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy PRIOR CONCURRENT THERAPY: No more than 1 previous chemotherapy regimen for metastatic melanoma No previous paclitaxel No chemotherapy, interferon, growth factors, interleukin, or radiotherapy (excluding gamma knife therapy for brain metastases) within the past 4 weeks No surgical resection of metastatic lesions within the past 4 weeks No other investigational medication within the past 4 weeks or during study No nitrosoureas (e.g., carmustine or lomustine) within the past 6 weeks and during study treatment No other concurrent chemotherapy, interferon, other growth factors, interleukin, illegal drugs, radiotherapy, surgery, or steroid therapy No concurrent oral or injectable hydrocortisone (at doses > 15 mg per day) or its equivalent
Sites / Locations
- University of Virginia Cancer Center