Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Primary To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation. Secondary To determine the median progression-free survival of patients treated with this regimen. To determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks for 1 year.

Official Title
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A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma

Conditions
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Intraocular Melanoma

Intervention / Treatment
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* Drug: nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan 18 years or older Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1 No known HIV or Hepatitis B or C Patients with brain metastasis are eligible for entry into the study Patients must have normal organ/marrow function as defined below: Absolute neutrophil count ≥ 1.5 x 109/L Platelets ≥ 100,000 x 109/L Hemoglobin ≥ 9.0 gm/100 ml Total bilirubin ≤ 1.5. In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.0. AST and ALT ≤ 2.5x upper limit of normal Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance > 50 mg ml. Calcium <12 mg/dl when corrected for levels of serum albumen Patients my have had up to one prior systemic therapy Exclusion Criteria: Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier. May not be receiving any other simultaneous investigational agents No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years. Patients who have serious infections or other major uncontrolled medical illnesses. Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe. Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study. Peripheral neuropathy of > grade 2.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nab-paclitaxel<br>Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. | Drug: nab-paclitaxel<br>* 150 mg/m2 weekly for 3 of 4 weeks every 28 days.<br>* Other names: paclitaxel protein-bound particles for injectable suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | up to 1 year following last treatment, for a total of approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel | up to 1 year following last treatment, for a total of approximately 5 years | 
| Overall Survival | Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive. | up to 1 year following last treatment, for a total of approximately 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ciliary body and choroid melanoma, medium/large size, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma, extraocular extension melanoma