Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
This study has been terminated.
(Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study)
Sponsor:
PhotoCure
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00708942
First received: July 1, 2008
Last updated: April 17, 2013
Last verified: April 2013
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Purpose
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Intraepithelial Neoplasia |
Drug: Hexaminolevulinate (HAL) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1) |
Resource links provided by NLM:
Further study details as provided by PhotoCure:
Primary Outcome Measures:
- Complete Response Rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Secondary Outcome Measures:
- Eradication of HPV [ Time Frame: 6 months ] [ Designated as safety issue: No ]High risk HPV
- Incidence of Patients With Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 83 |
| Study Start Date: | January 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
|
Drug: Hexaminolevulinate (HAL)
Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
|
|
Placebo Comparator: 2
Placebo suppository (single administration), laser illumination (50J/cm2)
|
Drug: Placebo
Placebo suppository, for 3-7 hours application
|
| No Intervention: 3 | |
|
Active Comparator: 4
HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)
|
Drug: Hexaminolevulinate (HAL)
Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
|
|
Placebo Comparator: 5
Placebo ointment (single administration), no illumination
|
Drug: Placebo
Placebo ointment for 5 hours application
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708942
Locations
| France | |
| Department of Obstetrics and Gyneacology, Lille University Hospital | |
| Lille, France | |
| Germany | |
| Department of Obstetrics and Gynecology | |
| Hannover, Germany | |
| Norway | |
| Fritzøe klinikk | |
| Larvik, Norway | |
| Department of Obstetrics and Gynaecology, Ullevål University Hospital | |
| Oslo, Norway | |
| Medicus | |
| Trondheim, Norway | |
Sponsors and Collaborators
PhotoCure
Investigators
| Principal Investigator: | Peter Hillemanns, MD, PhD | Medizinische Hochschule Hannover, Hannover, Germany |
More Information
No publications provided
| Responsible Party: | PhotoCure |
| ClinicalTrials.gov Identifier: | NCT00708942 History of Changes |
| Other Study ID Numbers: | PC CE201/08 |
| Study First Received: | July 1, 2008 |
| Results First Received: | March 4, 2013 |
| Last Updated: | April 17, 2013 |
| Health Authority: | Norway: Norwegian Medicines Agency Germany: Federal Institute for Drugs and Medical Devices France: Ministry of Health |
Keywords provided by PhotoCure:
|
Cervical intraepithelial neoplasia (CIN) |
Additional relevant MeSH terms:
|
Neoplasms Cervical Intraepithelial Neoplasia Carcinoma in Situ |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013