ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed melanoma Inoperable locally recurrent or metastatic disease Measurable disease No lytic or blastic bone metastasis as only evidence of metastasis Prior radiotherapy to a target lesion allowed provided there has been clear progression of disease since completion of radiotherapy No active brain metastasis, including leptomeningeal involvement Prior brain metastasis allowed provided the disease is in complete remission for at least 1 month after therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic AST and ALT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis) Bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception 1 month before and during study participation No pre-existing peripheral neuropathy ≥ grade 2 No prior allergy or hypersensitivity to study drug No concurrent clinically significant illness No other concurrent active malignancy No serious medical risk factors involving any of the major organ systems that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Recovered from prior chemotherapy More than 4 weeks since prior cytotoxic chemotherapy At least 3 weeks since prior anthracyclines No concurrent taxane or anthracyclines No concurrent doxorubicin Endocrine therapy No concurrent steroids except as needed for hypersensitivity to study drug Radiotherapy See Disease Characteristics Concurrent radiotherapy to a symptomatic non-target lesion (including recurrent or new brain metastases that develop during study participation) allowed Surgery Not specified Other More than 4 weeks since prior investigational drugs and recovered No other concurrent anticancer therapy No concurrent participation in another clinical study No other concurrent investigational therapies No concurrent ritonavir, saquinavir, indinavir, or nelfinavir
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA