Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT00738361
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00738361
Study Brief:
Protocol Section:
NCT00738361