Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256424
• Other study ID #: PC CE203/10
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2010
• Last updated: August 21, 2014
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last month

• Satisfactory colposcopy examination including:

• visibility of entire transformation zone including the squamocolumnar junction and

• visibility of entire lesion margin

• Negative endocervical os by colposcopy

• Colposcopical visible lesion at visit 2, before treatment

• Patients with an average sized uterine cervix (approximately 27mm diameter) suitable for application of the Klemcap

• Age 18 or above

• Written informed consent signed

Exclusion Criteria:

• Previous treatment of CIN or invasive disease

• Lesion(s) extending to the vaginal vault

• Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease

• Suspicion of endocervical disease on colposcopy

• Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination

• Undiagnosed vaginal bleeding

• History of toxic shock syndrome

• Known or suspected porphyria

• Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)

• Pregnancy, or intention to become pregnant during the study period

• Nursing

• Childbirth or miscarriage within six weeks of enrolment

• Use of heart pacemaker

• Participation in other clinical studies either concurrently or within the last 30 days

• Risk of poor protocol compliance. Patient participation should be considered with respect to living far away from the hospital, plans for moving to another city/state, frequent travelling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc.

• Unwillingness to use adequate birth control (not abstinence) from screening until last PDT

• Patient 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:
• HAL 5% with illumination
Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
• HAL 1% with illumination
Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
• HAL 0.2% with illumination
Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
• Placebo ointment without illumination
Treatment with a singe dose of 2g placebo ointment, no photoactivation

Locations

Country	Name	City	State
Germany	University Hospital Hannover	Hannover
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.	Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.	3 months after last treatment	No
Secondary	Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.	HPV response was defined as clearance of baseline HPV infection, asssessed by genotype	3 months after treatment	No