Spots Global Cancer Trial Database for Dose Escalating Study for Amphinex-based PCI of Bleomycin.

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Trial Identification

Brief Title: Dose Escalating Study for Amphinex-based PCI of Bleomycin.

Official Title: Dose Escalating Study to Evaluate the Tolerability, Efficacy and Safety of Amphinex 0.125 mg/kg or Lower in Amphinex-based PCI of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies.

Study ID: NCT01872923

Conditions

Cutaneous or Sub-cutaneous Malignancies

Interventions

Amphinex

Bleomycin

Laser

Study Description

Brief Summary: The primary goal of this extension study is to further investigate the tolerability and efficacy in a phase I setting in order to see whether lower doses than the initial study dose of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or improved safety and tolerability profile in combination with comparable signs of efficacy.

Detailed Description: Use of Amphinex for the enhancement of Bleomycin at the intracellular target. The photosensitizer Amphinex is activated by Laser Light at 652 nm. Superficial lesions (cutaneous or subcutaneous) was treated with the laser light after administration of Amphinex and Bleomycin according to time scheduled provided. Safety and preliminary effect data where evaluated at a lower dose than explored in the preceeding dose escalating study with Amphinex.