Dose Escalating Study for Amphinex-based PCI of Bleomycin.

NCT01872923 | Completed Phase 1

• 2 other identifiers: PCI 101/06 Extension2011-003750-80
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• To assess the combined tolerability and efficacy of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin

  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.

  From Baseline to 3 months

Secondary Outcomes (1)

• To evaluate the safety of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.

  From Baseline to 3 months

Other Outcomes (1)

• To determine the pharmacokinetics of Amphinex 0.125 mg/kg or lower in Amphinex-based PCI of bleomycin.

  From Baseline to 3 months

Study Arms (1)

Amphinex based PCI of bleomycin

EXPERIMENTAL

The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin

Drug: Amphinex; Drug: Bleomycin; Device: Laser

Interventions

Amphinex DRUG

Photosensitiser

Amphinex based PCI of bleomycin

Bleomycin DRUG

Anticancer agent

Amphinex based PCI of bleomycin

Laser DEVICE

Laser that emits red light at 652 nm.

Also known as: Ceralas PDT 652+/-3nm 2W" by CeramOptec GmbH CE0297

Amphinex based PCI of bleomycin

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 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.

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, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms; Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis

Interventions

Bleomycin; Lasers

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Martin Forster, MD

  UCLH

  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: May 27, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

GB (1)