To evaluate objective response rate and duration of response to weekly Taxoprexin®.
To evaluate the safety profile of weekly Taxoprexin® in this patient population.
To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic choroidal melanoma being treated with weekly Taxoprexin® Injection.
Who can participate
Age range13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Patients must have histologic or cytologic confirmation of malignant eye melanoma, and documented metastatic disease.
âś“. Patients must have at least one unidimensionally measurable lesion.
âś“. Patients may be previously untreated or may have received one prior systemic chemotherapy regimen for metastatic disease. Patients may not have been treated previously with taxanes. Prior treatment with immunotherapy or vaccine therapy is allowed.
âś“. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
âś“. At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow and prior adjuvant chemotherapy.
âś“. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
âś“. Patients must have Eastern Cooperative Oncology Group performance status of 0 - 2.
âś“. Patients must be at least 13 years of age.
Exclusion criteria
âś•. Patients who have received prior therapy with any taxane.
âś•. Patients whose site of primary melanoma is not in the choroid(eye).
âś•. Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
What they're measuring
1
Percentage of Participants Who Achieved an Objective Complete Response (CR) or Partial Response (PR)
Timeframe: Assessed every 6 weeks, up to 24 months
âś•. Patients with symptomatic brain metastasis (es).
âś•. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
âś•. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
âś•. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
âś•. Patients with unstable or serious concurrent medical conditions are excluded.