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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: paclitaxel albumin-stabilized nanoparticle formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel albumin-stabilized nanoparticle formulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage III melanoma, stage IV melanoma