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The best way to combine a loco-regional procedure such as chemoembolisation or radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying different schedules of administration of sorafenib after and before radioembolization. Secondly, we aim to evaluate angiogenic markers modifications during these different schedules, either in the serum or radiologicaly. Dose of Sorafenib will be 400 mg BID and the timing of introduction will differ for one cohort to the other, given after the radioembolization for initials cohorts and finally, before and concomitantly to radioembolization for the last cohort.
Full description
Primary objective:
To evaluate the safety and tolerability of sorafenib in combination with SIR-Spheres® radioembolization in uveal melanoma patients metastatic to the liver.
Secondary objectives:
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Inclusion criteria
Metastatic uveal melanoma with proven histology (stage IV)
Presence of liver metastases
Concomitant non life-threatening metastases outside the liver are allowed
Palliative radiotherapy will be allowed outside the liver
Previous chemotherapy or immunotherapy at least 4 weeks before study treatment is allowed
Age ≥ 18 years
ECOG Performance Status of 0 or 1
Life expectancy of at least 12 weeks
Subjects with at least one uni-dimensional (by RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to study treatment
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11 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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