Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms, Skin Neoplasms

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Colin Hopper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

PCI 101/06

NCT ID:

NCT00993512

Start Date:

August 2009

Completion Date:

May 2011

Related Keywords:

  • Head and Neck Neoplasms
  • Skin Neoplasms
  • photochemical internalisation
  • photosensitiser
  • cutaneous tumour
  • sub-cutaneous tumour
  • dose escalation
  • Neoplasms
  • Skin Neoplasms
  • Head and Neck Neoplasms

Name

Location