Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
Condition: Intraocular Melanoma
MeSH terms: Melanoma
Intervention: nab-paclitaxel
Intervention description: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ciliary body and choroid melanoma, medium/large size; iris melanoma; metastatic intraocular melanoma; recurrent intraocular melanoma; extraocular extension melanoma

Summary:

      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.
    

Eligibility criteria:

        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.