Head and Neck NeoplasmsPhase 1NCT00993512
Safety Study of Amphinex Based Photochemical Internalisation (PCI) of Bleomycin in Patients With Cutaneous Cancer
A Phase 1 study testing Amphinex (TPCS2a), Bleomycin and Illumination with CeramOptec laser in people with Head and Neck Neoplasms and Skin Neoplasms, run by PCI Biotech AS at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Skin Neoplasms
- What is being tested?
- Amphinex (TPCS2a), Bleomycin and Illumination with CeramOptec laser
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2PG
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Skin Neoplasms
- Being tested
- Amphinex (TPCS2a), Bleomycin, Illumination with CeramOptec laser
- Keywords
- photochemical internalisation, photosensitiser, cutaneous tumour, sub-cutaneous tumour, dose escalation
- Medical subject headings
- Head and Neck Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphinex (TPCS2a)Drug
Also called Amphinex
intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
BleomycinDrug
intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
Illumination with CeramOptec laserOther
intravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser.
| Study group | Role | What they receive |
|---|---|---|
| TPCS2a | Experimental | No comparative treatment is given in this open-label phase I, dose escalating safety study Receives: Drug: Amphinex (TPCS2a); Drug: Bleomycin; Other: Illumination with CeramOptec laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Measured: 28 days
Secondary outcomes (1)
Tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- PCI Biotech AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Hopper, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993512
- Sponsor's protocol ID
- PCI 101/06
- Status last verified
- Apr 2019
- First submitted
- 9 Oct 2009
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27475428
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00993512
- Acronym / sponsor ID
- PCI 101/06
- Conditions
- Head and Neck Neoplasms, Skin Neoplasms
- Keywords
- photochemical internalisation, photosensitiser, cutaneous tumour, sub-cutaneous tumour, dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PCI Biotech ASIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPCS2a | Experimental | Drug: Amphinex (TPCS2a), Drug: Bleomycin, Other: Illumination with CeramOptec laserNo comparative treatment is given in this open-label phase I, dose escalating safety study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphinex (TPCS2a)Also: Amphinexintravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser. | Drug | TPCS2a |
| Bleomycinintravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser. | Drug | TPCS2a |
| Illumination with CeramOptec laserintravenous TPCS2a, followed by standard dose of bleomycin (iv infusion) and illumination with CeramOptec laser. | Other | TPCS2a |
Primary outcome
Dose limiting toxicity
Time frame: 28 days
1 secondary outcome
Tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Derived from this study: PubMed 27475428Sultan 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.
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Hopper, MD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amphinex (TPCS2a), Bleomycin and Illumination with CeramOptec laser in people with Head and Neck Neoplasms and Skin Neoplasms, run by PCI Biotech AS at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.