Brief Title
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)
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
Secondary Outcome
Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
Condition
Cervical Intraepithelial Neoplasia
Intervention
HAL 5% with illumination
Study Arms / Comparison Groups
HAL 5% with illumination
Description: HAL PDT 5%
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
262
Start Date
April 2011
Completion Date
December 2012
Primary Completion Date
September 2012
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Peter Hillemanns, MD, PhD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01256424
Organization ID
PC CE203/10
Responsible Party
Sponsor
Study Sponsor
Photocure
Study Sponsor
Peter Hillemanns, MD, PhD, Principal Investigator, University Hospital Hannover
Verification Date
April 2016