Cervical Intraepithelial NeoplasiaPhase 2NCT00708942
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
A Phase 2 study testing Hexaminolevulinate (HAL) in people with Cervical Intraepithelial Neoplasia, run by Photocure at 5 sites in 3 countries.
Trial summary
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Hexaminolevulinate (HAL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Satisfactory colposcopy examination
- Negative endocervical canal by colposcopy
- Ectocervical CIN1 as verified by local pathologist (biopsy).
- Colposcopical visible lesion at visit 2, before photoactivation
- Written Informed Consent signed
- Age 18 or above
Who cannot join
- Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
- Malignant cells on cytology or histology
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
- Suspicion of endocervical disease on colposcopy
- Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination
- Known or suspected porphyria
Show all 15Show fewer
- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- Use of heart pacemaker
- Pregnancy
- Nursing
- Childbirth or miscarriage within six weeks of enrolment - Known
- Participation in other "competitive" clinical studies either concurrently or within the last 30 days
- Risk of poor protocol compliance
- Not willing to use adequate birth control from screening until last PDT
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Norway3 sites
Fritzøe klinikk
Larvik
Department of Obstetrics and Gynaecology, Ullevål University Hospital
Oslo
Medicus
Trondheim
France1 site
Department of Obstetrics and Gyneacology, Lille University Hospital
Lille
About this study
Official title: A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
Read the detailed description
Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.
In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Hexaminolevulinate (HAL), Placebo
- Keywords
- Cervical intraepithelial neoplasia (CIN)
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexaminolevulinate (HAL)Drug
Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
PlaceboDrug
Placebo suppository, for 3-7 hours application
Hexaminolevulinate (HAL)Drug
Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
PlaceboDrug
Placebo ointment for 5 hours application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2) Receives: Drug: Hexaminolevulinate (HAL) |
| 2 | Placebo comparator | Placebo suppository (single administration), laser illumination (50J/cm2) Receives: Drug: Placebo |
| 3 | No intervention | Not described |
| 4 | Active comparator | HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2) Receives: Drug: Hexaminolevulinate (HAL) |
| 5 | Placebo comparator | Placebo ointment (single administration), no illumination Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Measured: 6 month
Secondary outcomes (2)
Eradication of HPV
High risk HPV
Measured: 6 months
Incidence of Patients With Adverse Events
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 posted3 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Hillemanns, MD, PhD, Principal investigator, Medizinische Hochschule Hannover, Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708942
- Sponsor's protocol ID
- PC CE201/08
- Status last verified
- Apr 2013
- First submitted
- 1 Jul 2008
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
- ClinicalTrials.gov ID
- NCT00708942
- Acronym / sponsor ID
- PC CE201/08
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Cervical intraepithelial neoplasia (CIN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study
- Enrolment
- 83 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Posted 15 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
Detailed description
Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.
In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Hexaminolevulinate (HAL)HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2) |
| 2 | Placebo comparator | Drug: PlaceboPlacebo suppository (single administration), laser illumination (50J/cm2) |
| 3 | No intervention | – |
| 4 | Active comparator | Drug: Hexaminolevulinate (HAL)HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2) |
| 5 | Placebo comparator | Drug: PlaceboPlacebo ointment (single administration), no illumination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Satisfactory colposcopy examination
- Negative endocervical canal by colposcopy
- Ectocervical CIN1 as verified by local pathologist (biopsy).
- Colposcopical visible lesion at visit 2, before photoactivation
- Written Informed Consent signed
Key exclusion criteria (15 listed)
- Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
- Malignant cells on cytology or histology
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
- Suspicion of endocervical disease on colposcopy
- Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination
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 |
|---|---|---|
| Hexaminolevulinate (HAL)Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application | Drug | 1 |
| PlaceboPlacebo suppository, for 3-7 hours application | Drug | 2 |
| Hexaminolevulinate (HAL)Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application | Drug | 4 |
| PlaceboPlacebo ointment for 5 hours application | Drug | 5 |
Primary outcome
Complete Response Rate
Time frame: 6 month
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
2 secondary outcomes
Eradication of HPV
Time frame: 6 months
Incidence of Patients With Adverse Events
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Intraepithelial Neoplasia
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
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.
Peter Hillemanns, MD, PhD principal investigator
Medizinische Hochschule Hannover, Hannover, Germany
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hexaminolevulinate (HAL) in people with Cervical Intraepithelial Neoplasia, run by Photocure at 5 sites in 3 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 6 inclusion and 15 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 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway, France, Germany. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Response Rate (time frame: 6 month). 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 24 Apr 2013.