Genasense, Carboplatin, Paclitaxel (GCP) Combination in Uveal Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Genasense; Paclitaxel; Carboplatin
Intervention description: 900 mg by vein over 1 hour on Days 1, 3, and 5 of a 21 day cycle.; 175 mg/m^2 by vein over 3 hours on Day 3 of a 21 day cycle following Genasense.; Carboplatin starting dose in mg (AUC= 6) is administered over 30 minutes IV Piggyback (IVPB). Carboplatin will be dosed after Paclitaxel dose on Day 3 every 3 weeks.
The total dose of Carboplatin is calculated using a formula based upon a participant's glomerular filtration rate (GFR in mL/min) and Carboplatin target area under the concentration (AUC).
Intervention MeSH terms: Paclitaxel; Carboplatin; Oblimersen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveal melanoma; Carboplatin; Genasense; Paclitaxel; oblimersen; GCP

Summary:

      The goal of this clinical research is to learn if the combination of Genasense (oblimersen),
      carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety
      of this combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a history of uveal melanoma and documented metastatic disease

          2. Patients must have at least one measurable lesion as per revised RECIST Criteria. A
             measurable lesion is defined as a non-nodal lesions that is >/= 10 mm provided the CT
             slice is </=5 mm in thickness or a pathologic lymph node that is >/= 15 mm on the
             short axis provided the CT slice is </= 5 mm in thickness or Superficial skin lesion
             that is >/= 10 mm in diameter as assessed using calipers. Bone lesions are not
             considered measurable.

          3. Patients may be previously untreated or may have received prior systemic therapy but
             no more than one systemic cytotoxic chemotherapy regimen and one targeted therapy for
             metastatic disease.

          4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine
             or other therapy unless patients have progressed during therapy. If progression
             occurred during therapy, patient must have recovered from any side effects before
             starting GCP therapy.

          5. At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow.

          6. Lesions being used to assess disease status may not have been radiated or if so, must
             have progressed during or after radiation therapy.

          7. Patients must have ECOG performance status of 0 - 2.

          8. Patients should be 18 years of age or older.

          9. Patients must have adequate liver and renal function as defined by total bilirubin
             </=1.5 mg/dl, serum Lactate Dehydrogenase level no higher than 2.0 x UNL of the
             institution, transaminase (i.e., ALT and AST) levels no higher than 5 x UNL and serum
             creatinine </=1.5 mg/dl or estimated Creatinine Clearance >/=60 ml/min

         10. Patients must have adequate bone marrow function as defined by an absolute neutrophil
             count of greater or equal to 1,500/mm3, and platelet count of greater or equal to
             100,000/mm3.

         11. Patients must sign an informed consent form indicating that they are aware of the
             investigational nature of this study and in keeping with the policies of the
             institution.

         12. Females of childbearing potential (non childbearing is defined as greater than one
             year post-menopausal or surgically sterilized) must use acceptable contraceptive
             methods (abstinence, intrauterine device, oral contraceptive or double barrier
             device), and must have a negative serum or urine pregnancy test within 7 days prior to
             beginning treatment on this trial. Sexually active men must also use acceptable
             contraceptive methods for the duration of time on study.

        Exclusion Criteria:

          1. Patients who have received prior therapy with Genasense, any taxane or any of
             cisplatin analogues for systemic disease.

          2. Patients whose site of primary melanoma is not in the choroid.

          3. Patients who have a current history of neoplasm other than the entry diagnosis, except
             for curatively treated non-melanoma skin cancer or carcinoma in situ of the prostate
             or cervix or other cancers treated for cure and with a disease-free survival longer
             than 2 years.

          4. Patients with brain metastasis or history of brain metastasis (es).

          5. Patients who are pregnant or breastfeeding.

          6. Patients with current active infections requiring anti-infectious treatment (e.g.,
             antibiotics, antivirals, or antifungals).

          7. Patients with current peripheral neuropathy of any etiology that is greater than grade
             one (1).

          8. Patients with unstable or serious concurrent medical conditions are excluded. Examples
             include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3
             months) myocardial infarction, uncontrolled major seizure disorder, spinal cord
             compression, superior vena cava syndrome, or any psychiatric disorder that prohibits
             obtaining informed consent. PI or his designee shall make the final determination
             regarding appropriateness of enrollment.

          9. Patients with a known hypersensitivity to cremophor containing anti-cancer agents.

         10. Patients with one or more of the following as the only manifestations of disease are
             ineligible: Osteoblastic bone lesions, leptomeningeal disease, ascites,
             pleural/pericardial effusions, carcinomatous lymphangitis, CNS metastases, lesions in
             a previously irradiated area that have not shown definite progression, or disease only
             inferred from laboratory tests or markers.

         11. Patients with Gilbert's Syndrome.

         12. Patients must not have had major surgery within the past 14 days.

         13. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy
             while on study.

         14. Known HIV disease or infection.