Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer

NCT00993512 | Completed Phase 1 DMC

• 1 other identifier: PCI 101/06
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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, cutaneous or sub-cutaneous malignancies.

Conditions

Head and Neck Neoplasms; Skin Neoplasms

Keywords

photochemical internalisation; photosensitiser; cutaneous tumour; sub-cutaneous tumour; dose escalation

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  28 days

Secondary Outcomes (1)

• Tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST)

  3 months

Study Arms (1)

TPCS2a

EXPERIMENTAL

No comparative treatment is given in this open-label phase I, dose escalating safety study

Drug: Amphinex (TPCS2a); Drug: Bleomycin; Other: Illumination with CeramOptec laser

Interventions

Amphinex (TPCS2a) DRUG

intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.

Also known as: Amphinex

TPCS2a

Bleomycin DRUG

intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.

TPCS2a

Illumination with CeramOptec laser OTHER

intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.

TPCS2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PCI Biotech AS: lead

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

• Sultan AA, Jerjes W, Berg K, Hogset A, Mosse CA, Hamoudi R, Hamdoon Z, Simeon C, Carnell D, Forster M, Hopper C. Disulfonated tetraphenyl chlorin (TPCS2a)-induced photochemical internalisation of bleomycin in patients with solid malignancies: a phase 1, dose-escalation, first-in-man trial. Lancet Oncol. 2016 Sep;17(9):1217-29. doi: 10.1016/S1470-2045(16)30224-8. Epub 2016 Jul 28.

  PMID: 27475428 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Skin Neoplasms

Interventions

Bleomycin; Lighting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Colin Hopper, MD

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

GB (1)