Clinical trial NCT01256424: Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
timeFrame: 3 months after last treatment
Secondary outcomes:
measure: Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: University Hospital Hannover
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: University Hospital Hannover
name: Peter Hillemanns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.