Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00708942
• Other study ID #: PC CE201/08
• Status: Terminated
• Phase: Phase 2
• First received: July 1, 2008
• Last updated: April 17, 2013
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: April 2013
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesFrance: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Drug:
• Hexaminolevulinate (HAL)
Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
• Placebo
Placebo suppository, for 3-7 hours application
• Hexaminolevulinate (HAL)
Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
• Placebo
Placebo ointment for 5 hours application

Locations

Country	Name	City	State
France	Department of Obstetrics and Gyneacology, Lille University Hospital	Lille
Germany	Department of Obstetrics and Gynecology	Hannover
Norway	Fritzøe klinikk	Larvik
Norway	Department of Obstetrics and Gynaecology, Ullevål University Hospital	Oslo
Norway	Medicus	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Countries where clinical trial is conducted

France,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.	6 month	No
Secondary	Eradication of HPV	High risk HPV	6 months	No
Secondary	Incidence of Patients With Adverse Events		3 months	Yes