Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer
Information source: PCI Biotech AS
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Neoplasms; Skin Neoplasms
Intervention: Amphinex (TPCS2a) (Drug); Bleomycin (Drug); Illumination with CeramOptec laser (Other)
Phase: Phase 1
Status: Recruiting
Sponsored by: PCI Biotech AS Official(s) and/or principal investigator(s):
Colin Hopper, MD, Principal Investigator, Affiliation: University College London Hospitals
Overall contact:
Colin Hopper, Phone: +44 7903113675
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, cutaneous or sub-cutaneous malignancies.
Clinical Details
Official title: Phase I, Dose-escalating Study to Evaluate Safety and Tolerance of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Dose limiting toxicity
Secondary outcome: Tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST)
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 illumination, with red light (laser 652 nm), to the tumour
surface and a margin of 2-3 mm outside the tumour surface, will be performed after bleomycin
administration.
There will be no comparative procedure in this study. Dose escalation will proceed according
to a modification of Simon's accelerated titration design. The number of patients recruited
depends on the DLT experienced. A total of 6 patients will be included at each dose level if
no more than 1 patient experiences DLT.
Additional cohorts may be added pending the outcome of the previous cohorts and discussions
between the investigators and the Sponsor. The primary goal of the study is to assess the
safety and tolerance of the Amphinex and determine the maximal tolerated dose (MTD) of
Amphinex as a PCI therapy in combination with bleomycin treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Colin Hopper, Phone: +44 7903113675
University College London Hospital, London NW1 2PG, United Kingdom; Recruiting
Colin Hopper, Phone: +44 7903113675, Email: c.hopper@ucl.ac.uk
Colin Hopper, Principal Investigator
Additional Information
Starting date: August 2009
Last updated: October 9, 2009
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