Dose Escalating Study for Amphinex-based PCI of Bleomycin.
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|ClinicalTrials.gov Identifier: NCT01872923|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : June 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous or Sub-cutaneous Malignancies||Drug: Amphinex Drug: Bleomycin Device: Laser||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||February 2013|
Experimental: Amphinex based PCI of bleomycin
The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin
Laser that emits red light at 652 nm.
Other Name: Ceralas PDT 652+/-3nm 2W" by CeramOptec GmbH CE0297
- To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin [ Time Frame: From Baseline to 3 months ]
Maximal pain during the procedure will be recorded immediately after the procedure on a 10 centimetre visual analogue scale (VAS). Pain will also be recorded 24 hours after the illumination and on day 4. The end-points of the VAS will be "no pain" and "unbearable pain
A formal efficacy analysis is not appropriate for this trial. The response data will be documented by descriptive summary tables. No statistical comparison of dose levels will be done. Fluorescence measurements over time and lesion response evaluation according to RECIST (see Appendix E) will be presented for APT and PP stratified by dose level.
- To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin. [ Time Frame: From Baseline to 3 months ]
- Summaries of the adverse event rates and laboratory changes from baseline stratified by dose level.
- Listings and frequency tables categorizing laboratory and non-laboratory adverse events by maximum CTCAE toxicity grade and relationship to study drug.
- Pain measurement, fluorescence measurement, skin photosensitivity measurement
- To determine the pharmacokinetics of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin. [ Time Frame: From Baseline to 3 months ]
Plasma samples for pharmacokinetic (PK) evaluation will be collected from patients and the presence of Amphinex and/or other unidentified metabolites will be assessed using a validated analytical method
Systematic skin photosensitivity tests will be carried out using a white light source with an emission spectrum that, relatively to the luminance and within +/- 50%, excites Amphinex with the same efficiency as sunlight. The luminance will be 500 lux, which is comparable to bright indoor light, and 100.000 lux, which is comparable to direct sunlight. The phototoxic reaction will be scored at specific time points following the light exposure (see the study flowchart Appendix B). This information will be used to predict the degree of photosensitivity of the skin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872923
|University College London Hospital|
|London, United Kingdom|
|Principal Investigator:||Martin Forster, MD||UCLH|