Clinical trial NCT01872923: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cutaneous or Sub-cutaneous Malignancies
Keywords: Amphinex
PCI
Bleomycin
Cutaneous malignancies
Sub-cutaneous malignancies
Safety
Phase I
Photochemical Internalisation
Squamous Cell Carcinoma
Head and Neck cancer
Breast Cancer
HNSCC
SCCHN
Advanced or metastatic cancer
Dose finding
Lead sponsor: PCI Biotech AS
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 any other investigational therapy or radiotherapy for at least 2 weeks prior to administration of Amphinex at the baseline visit, and have recovered from the acute effects of therapy
  * Have discontinued cytostatic or cytotoxic therapies with at least 6 half life cycles of the agent prior to administration of Amphinex at the baseline visit
  * 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.

Primary outcomes:
measure: To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin
timeFrame: From Baseline to 3 months
Secondary outcomes:
measure: To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.
timeFrame: From Baseline to 3 months
Other outcomes:
measure: To determine the pharmacokinetics of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.
timeFrame: From Baseline to 3 months
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: UCLH
name: Martin Forster, MD
role: PRINCIPAL_INVESTIGATOR
References: