Status:
COMPLETED
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
National Comprehensive Cancer Network
Celgene Corporation
Conditions:
Intraocular Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 stopp...
Detailed Description
OBJECTIVES: Primary * To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation. Secondary ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00738361
Start Date
August 1 2008
End Date
April 1 2013
Last Update
February 12 2016
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210