Recurrent Head and Neck CancerPhase 2NCT01606566
A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer.
A Phase 2 study testing Amphinex induced PCI of bleomycin in people with Recurrent Head and Neck Cancer and Carcinoma, Squamous Cell of Head and Neck, run by PCI Biotech AS at 10 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin ('PC-A11') with superficial and/or interstitial laser light application in patients with recurrent SCCHN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Cancer, Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- Amphinex induced PCI of bleomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Apr 2012to Jan 2016
- Phase
- Phase 2
- 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
- Study eligibility reviewed and approved by interdisciplinary hospital team.
- Age minimum 18 years.
- Histologically or cytological confirmed diagnosis of recurrent or metastatic SCCHN considered unsuitable for surgery and radiotherapy (patients with distant or regional metastatic disease may be eligible if local palliation is needed)
- Performance status (WHO scale/ECOG) ≤ 1.
- At least one measurable target lesion at baseline.
- Local disease including margin (0.5 cm) treatable with superficial and/or interstitial laser light application (for superficial lesions: entire tumour assessable for laser light application/interstitial treatment: insertion of implants feasible)
- Estimated life expectancy of at least 12 weeks.
- Written informed consent.
Who cannot join
- Prior Treatment:
- Local treatment of their SCCHN by surgery within the previous 4 weeks or by radiation within the previous 3 months.
- Previous treatment with systemic chemotherapy for their SCCHN within the last 4 weeks
- Previous treatment with Photodynamic Therapy within the last 6 months.
- Prior treatment with bleomycin.
- Prior treatment with PC-A11.
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- Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) which did not resolve to ≤ grade 2.
- Current Treatment:
- Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
- Other concurrent anticancer therapies.
- Treatment with a medicinal product with known or potential drug-drug interaction with bleomycin or Amphinex.
- Haematology, coagulation and biochemistry:
- Inadequate bone marrow function:
- Absolute Neutrophil Count (ANC): < 1.5 x 109/L, or platelet count <100 x 109/L or haemoglobin < 6 mmol/L.
- Inadequate liver function, defined as:
- Serum (total) bilirubin > 2 x the Upper Limit of Normal (ULN) for the institution.
- Aspartate Amino Transferase (ASAT) or Alanine Amino Transferase (ALAT) > 2.5 x ULN.
- Alkaline phosphatase levels > 2.5 x ULN.
- Glomerular filtration rate (GFR) < 30ml/min.
- Clinical significant electrolyte abnormalities (Potassium, Magnesium, Phosphate that is greater than CTCAE grade 3 for both low and high values)
- Other:
- Tumours known or suspected to be eroding into a major blood vessel, e.g. carotid artery (interna and /or communis) in or adjacent to the illumination site (minimum distance between tumour tissue and critical structure should be 0.5 cm).
- Nasopharyngeal carcinoma.
- Conditions contraindicated for bleomycin treatment (current lung infection, severely impaired pulmonary function) excluded by lung function test (either formal lung function test for patients able to undertake such assessment, or a suitable opinion by an appropriately trained Respiratory / Anaesthetic Clinical Specialist).
- Conditions that worsen when exposed to light (including porphyria).
- Inability to undergo CT or MRI.
- Pregnancy or lactation (female patients with childbearing potential). Serum pregnancy test to be performed within 7 days prior to study PC-A11 treatment start, or within 14 days followed by a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients who are not surgically sterile or with female partners of childbearing potential: absence of highly effective method of contraception resulting in a low failure rate (i.e. less than 1% per year). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy. Note: Abstinence is only acceptable as true abstinence: when this is in line with the preferred and usual lifestyle of the subject, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Planned surgery, endoscopic examination or dental treatment in first 30 days after PC-A11 treatment.
- Co-existing ophthalmic disease likely to require slit-lamp examination within the first 90 days after PC-A11 treatment.
- Congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except for atrioventricular block type I, Mobitz type II, and Wenckebach type) signs and symptoms of relevant cardiovascular disease.
- Known allergy or sensitivity to photosensitisers.
- Ataxia telangiectasia
- Concomitant malignant disease, with exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
- Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, physical examination or laboratory findings) that may interfere with the planned PC-A11 treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Germany4 sites
Charité Comprehensive Cancer Center
Berlin, 10117
Universitätsklinikum Essen
Essen, 45147
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Ludwig Maximilian University Munich
München
France2 sites
Centre Alexis Vautrin (CAV)-Nancy Université
Nancy
CHU de Nantes Hôtel Dieu
Nantes, Nantes Cedex 1, 44093
Netherlands1 site
The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
Amsterdam
About this study
Official title: Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Cancer
The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin ('PC-A11') with superficial and/or interstitial laser light application in patients with recurrent SCCHN.
Read the detailed description
Approximately 650 000 new cases of head and neck cancer are diagnosed worldwide each year (2). Europe alone, it is estimated that there are approximately 143 000 new cases and more than 68 000 deaths each year (3). The vast majority (>90%) of head and neck malignancies are squamous cell carcinomas. Most (60-70%) patients with squamous cell carcinoma of the head and neck (SCCHN) present with loco regionally advanced disease.
Standard treatment options for SCCHN include surgery, radiotherapy and chemotherapy. Single-modality treatment with surgery or radiotherapy is generally recommended for the 40% of patients who present stage I or II disease. Each of the two modalities results in similar survival with cure rates ranging between 60% and 90%.
For the 60% of the patients who present with locally advanced disease at diagnosis, combined modality therapy is generally recommended. For patients with unresectable disease the current standard treatment is concurrent cisplatin-based chemoradiation. This is also the standard for patients with resectable disease when organ preservation is desired and, as adjuvant treatment, for patients with high-risk pathological findings at surgical resection.
Despite such an approach, a substantial percentage of patients (20-30%) develop local and/or regional recurrences and distant metastases. Recurrent disease is often not resectable, and even in resectable cases, some patients decline the surgical procedure due to quality of life considerations. Additionally, in recurrent disease the radiation tolerance of the normal tissues makes re-irradiation technically challenging and frequently more toxic than the initial course. The prognosis of patients with recurrent or metastatic SCCHN is generally poor, with a median survival of 6-9 months.
The therapeutic ratio in recurrent SCCHN is narrow. Therefore, there is a large unmet medical need for novel treatments in this patient group, both to lengthen overall survival, and to improve the patients' quality of life.
- Being tested
- Amphinex induced PCI of bleomycin
- Keywords
- Recurrent, Head and Neck, Neoplasms, Squamous Cell Carcinoma, Amphinex, Cancer, Photodynamic therapy, Chemotherapy, Bleomycin
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphinex induced PCI of bleomycinDrug
Also called Blenoxane
Intravenous administration of 0.25 mg/kg Amphinex (day 0) followed by intravenous administration of bleomycin (15000 IU/m2, day 4) and laser light application (3 hours (+/- 1 hour) after bleomycin administration).
| Study group | Role | What they receive |
|---|---|---|
| Amphinex induced PCI of bleomycin | Experimental | Drug: Amphinex induced PCI of bleomycin
Intervention:Intravenous administration of Amphinex (day 0) followed by intravenous administration of bleomycin and laser light application (day 4). Laser light application could be both interstitial and/or superficial depending on the tumour location. Receives: Drug: Amphinex induced PCI of bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
The 'run-in part' primary endpoint
Measured: 3 months
The proportion of patients with non-progressive local disease at 6 months
The expansion part primary endpoint
Measured: 6 months
Secondary outcomes (5)
Pharmacokinetics of 'PC-A11' in plasma
The run-in part and expansion part secondary endpoint
Measured: 3 months
The proportion of patients with non-progressive local disease at 3 months
The run-in part and expansion part secondary endpoint
Measured: 12 months
Proportion of patients with adverse events
The run-in part and expansion part safety endpoint
Measured: 12 months
Progression free survival
The run-in part and expansion part secondary outcome measure
Measured: 12 months
QoL using EORTC Quality of Life Questionnaire (QLQ)-C30 version 3.0 and QLQ-H&N35
The run-in part and expansion part secondary outcome measures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2015
- Study completionJan 2016
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- PCI Biotech AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baris Karakullukcu, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606566
- Sponsor's protocol ID
- PCIA202/10
- Other IDs
- 2011-003751-19
- Status last verified
- Feb 2022
- First submitted
- 21 May 2012
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01606566
- Acronym / sponsor ID
- PCIA202/10
- Keywords
- Recurrent, Head and Neck, Neoplasms, Squamous Cell Carcinoma, Amphinex, Cancer, Photodynamic therapy, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 26 participants (actual)
- Lead sponsor
- PCI Biotech ASIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 May 2012 (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.
The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin ('PC-A11') with superficial and/or interstitial laser light application in patients with recurrent SCCHN.
Detailed description
Approximately 650 000 new cases of head and neck cancer are diagnosed worldwide each year (2). Europe alone, it is estimated that there are approximately 143 000 new cases and more than 68 000 deaths each year (3). The vast majority (>90%) of head and neck malignancies are squamous cell carcinomas. Most (60-70%) patients with squamous cell carcinoma of the head and neck (SCCHN) present with loco regionally advanced disease.
Standard treatment options for SCCHN include surgery, radiotherapy and chemotherapy. Single-modality treatment with surgery or radiotherapy is generally recommended for the 40% of patients who present stage I or II disease. Each of the two modalities results in similar survival with cure rates ranging between 60% and 90%.
For the 60% of the patients who present with locally advanced disease at diagnosis, combined modality therapy is generally recommended. For patients with unresectable disease the current standard treatment is concurrent cisplatin-based chemoradiation. This is also the standard for patients with resectable disease when organ preservation is desired and, as adjuvant treatment, for patients with high-risk pathological findings at surgical resection.
Despite such an approach, a substantial percentage of patients (20-30%) develop local and/or regional recurrences and distant metastases. Recurrent disease is often not resectable, and even in resectable cases, some patients decline the surgical procedure due to quality of life considerations. Additionally, in recurrent disease the radiation tolerance of the normal tissues makes re-irradiation technically challenging and frequently more toxic than the initial course. The prognosis of patients with recurrent or metastatic SCCHN is generally poor, with a median survival of 6-9 months.
The therapeutic ratio in recurrent SCCHN is narrow. Therefore, there is a large unmet medical need for novel treatments in this patient group, both to lengthen overall survival, and to improve the patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphinex induced PCI of bleomycin | Experimental | Drug: Amphinex induced PCI of bleomycinDrug: Amphinex induced PCI of bleomycin Intervention:Intravenous administration of Amphinex (day 0) followed by intravenous administration of bleomycin and laser light application (day 4). Laser light application could be both interstitial and/or superficial depending on the tumour location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Study eligibility reviewed and approved by interdisciplinary hospital team.
- Age minimum 18 years.
- Histologically or cytological confirmed diagnosis of recurrent or metastatic SCCHN considered unsuitable for surgery and radiotherapy (patients with distant or regional metastatic disease may be eligible if local palliation is needed)
- Performance status (WHO scale/ECOG) ≤ 1.
- At least one measurable target lesion at baseline.
Key exclusion criteria (35 listed)
- Local treatment of their SCCHN by surgery within the previous 4 weeks or by radiation within the previous 3 months.
- Previous treatment with systemic chemotherapy for their SCCHN within the last 4 weeks
- Previous treatment with Photodynamic Therapy within the last 6 months.
- Prior treatment with bleomycin.
- Prior treatment with PC-A11.
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 induced PCI of bleomycinAlso: BlenoxaneIntravenous administration of 0.25 mg/kg Amphinex (day 0) followed by intravenous administration of bleomycin (15000 IU/m2, day 4) and laser light application (3 hours (+/- 1 hour) after bleomycin administration). | Drug | Amphinex induced PCI of bleomycin |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: 3 months
The 'run-in part' primary endpoint
The proportion of patients with non-progressive local disease at 6 months
Time frame: 6 months
The expansion part primary endpoint
5 secondary outcomes
Pharmacokinetics of 'PC-A11' in plasma
Time frame: 3 months
The proportion of patients with non-progressive local disease at 3 months
Time frame: 12 months
Proportion of patients with adverse events
Time frame: 12 months
Progression free survival
Time frame: 12 months
QoL using EORTC Quality of Life Questionnaire (QLQ)-C30 version 3.0 and QLQ-H&N35
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
Baris Karakullukcu, MD principal investigator
The Netherlands Cancer Institute
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amphinex induced PCI of bleomycin in people with Recurrent Head and Neck Cancer and Carcinoma, Squamous Cell of Head and Neck, run by PCI Biotech AS at 10 sites in 6 countries.
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 8 inclusion and 35 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: stopped early, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, France, Lithuania, Netherlands, Poland and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Business reasons). Results are not available in the source record.
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 toxicities (DLT) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.