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Los Angeles, California 90095


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Antoni Ribas, MD
Jonsson Comprehensive Cancer Center

Backup Contact:


Location Contact:

Los Angeles, California 90095
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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