abi-007 in treating patients with inoperable locally recurrent or metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy, such as abi-007, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well abi-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.

objectives: primary * determine the antitumor activity of abi-007 in patients with inoperable locally recurrent or metastatic melanoma. * determine the safety and tolerability of this drug in these patients. secondary * determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug. * determine the survival of patients treated with this drug. * determine the effects of this drug on biomarkers of melanoma in these patients. * correlate biomarker levels with response in patients treated with this drug. outline: this is an open-label, multicenter study. patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic chemotherapy (previously treated vs chemotherapy-naïve). * cohort i (previously treated): patients receive abi-007 iv over 30 minutes on days 1, 8, and 15. * cohort ii (chemotherapy-naïve): patients receive a higher dose of abi-007 as in cohort i. in both cohorts, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. patients are followed monthly for 6 months and then every 3 months thereafter. projected accrual: a total of 24-70 patients (12-35 per cohort) will be accrued for this study.

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

Keywords: recurrent melanoma stage iii melanoma stage iv melanoma