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

NCT ID: NCT01256424

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-12-31

Brief 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).

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HAL 5% with illumination

HAL PDT 5%

Group Type: EXPERIMENTAL

HAL 5% with illumination

Intervention Type: DRUG

Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation

HAL 1% with illumination

HAL PDT 1%

Group Type: EXPERIMENTAL

HAL 1% with illumination

Intervention Type: DRUG

Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation

HAL 0.2% with illumination

HAL PDT 0.2%

Group Type: EXPERIMENTAL

HAL 0.2% with illumination

Intervention Type: DRUG

Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation

Placebo ointment without illumination

Placebo without illumination

Group Type: PLACEBO_COMPARATOR

Placebo ointment without illumination

Intervention Type: DRUG

Treatment with a singe dose of 2g placebo ointment, no photoactivation

Interventions

HAL 5% with illumination

Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation

Intervention Type: DRUG

HAL 1% with illumination

Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation

Intervention Type: DRUG

HAL 0.2% with illumination

Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation

Intervention Type: DRUG

Placebo ointment without illumination

Treatment with a singe dose of 2g placebo ointment, no photoactivation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Photocure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hillemanns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hannover

Locations

University Hospital Hannover

Hanover, , Germany

Haukeland University Hospital

Bergen, , Norway

Countries

Germany; Norway

References

Hillemanns P, Garcia F, Petry KU, Dvorak V, Sadovsky O, Iversen OE, Einstein MH. A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2. Am J Obstet Gynecol. 2015 Apr;212(4):465.e1-7. doi: 10.1016/j.ajog.2014.10.1107. Epub 2014 Oct 31.

Reference Type: DERIVED

PMID: 25467012 (View on PubMed)

Other Identifiers

PC CE203/10

Identifier Type: -

Identifier Source: org_study_id