Status:
COMPLETED
Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer
Lead Sponsor:
PCI Biotech AS
Conditions:
Head and Neck Neoplasms
Skin Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, ...
Detailed Description
Eligible patients will be included in cohorts of 3 patients. The initial starting dose for Amphinex will be given 4 days prior to the fixed dose of bleomycin administered by intravenous infusion. The ...
Eligibility Criteria
Inclusion
- Male or female aged 18 years or above who have given written informed consent.
- Skin type I- IV according to the Fitzpatrick skin classification (see appendix G).
- With a diagnosis of local recurrence or advanced/metastatic, cutaneous or subcutaneous malignancy
- Lesion measurement must not be done more than 2 weeks before the beginning of treatment. More than one field with lesion can be illuminated, but care must be taken to avoid overlap of the fields illuminated.
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy for at least 2 weeks prior to study entry, and have recovered from the acute effects of therapy.
- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see appendix D).
- Clinically assessed as eligible for bleomycin chemotherapy.
- Have a predicted life expectancy of at least 3 months.
- Geographic proximity that allow adequate follow-up.
- If female: have had childbearing potential either terminated by surgery, radiation, or menopause or attenuated by the use of an approved contraceptive method during and for 3 months after the trial.
- If male: have had reproductive potential either terminated or attenuated by the use of an approved contraceptive method during and for 3 months after the trial.
Exclusion
- Have received prior PCI.
- Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
- Planned surgery in first 28 days after treatment, except for planned surgical removal of the treated lesion.
- Planned dentist appointments in first 28 days after treatment.
- Anticancer therapy within the first 28 days after treatment.
- Therapy with drugs that induce light sensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea, hypoglycemic agents, thiazide diuretics, and griseofulvin) within the first 14 days after treatment.
- Co-existing ophthalmic disease likely to require slit-lamp examination within the first 28 days after treatment.
- History of hypersensitivity/anaphylactic reactions.
- Previous cumulative dose of Bleomycin received over 200 000 IE
- Known allergy or sensitivity to photosensitisers.
- Known allergy to Cremophor.
- Known allergy to bleomycin.
- Conditions contraindicated for bleomycin treatment (lung infection, impaired pulmonary function).
- Conditions that worsen when exposed to light (including porphyria).
- Conditions associated with a risk of poor protocol compliance.
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00993512
Start Date
August 1 2009
End Date
May 1 2011
Last Update
April 29 2019
Active Locations (1)
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1
University College London Hospital
London, United Kingdom, NW1 2PG