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

Purpose

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).

Condition	Intervention	Phase
Cervical Intraepithelial Neoplasia	Drug: Cervical PDT using Hexaminolevulinate	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluoxymesterone Hexaminolevulinate

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:

To compare lesion response rates of three different doses of HAL PDT and placebo at 3 months after treatment. [ Time Frame: 3 months after last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare safety and HPV response of three different doses of HAL PDT and placebo at 3 months after treatment. [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HAL 5% with illumination HAL PDT 5%	Drug: Cervical PDT using Hexaminolevulinate Treatment with a singe dose of 2g, HAL 0.2%, HAL 1%, HAL 5% or placebo ointment followed by photoactivation
Experimental: HAL 1% with illumination HAL PDT 1%	Drug: Cervical PDT using Hexaminolevulinate Treatment with a singe dose of 2g, HAL 0.2%, HAL 1%, HAL 5% or placebo ointment followed by photoactivation
Experimental: HAL 0.2% with illumination HAL PDT 0.2%	Drug: Cervical PDT using Hexaminolevulinate Treatment with a singe dose of 2g, HAL 0.2%, HAL 1%, HAL 5% or placebo ointment followed by photoactivation
Placebo Comparator: Placebo ointment without illumination Placebo without illumination	Drug: Cervical PDT using Hexaminolevulinate Treatment with a singe dose of 2g, HAL 0.2%, HAL 1%, HAL 5% or placebo ointment followed by photoactivation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256424

Locations

Germany
University Hospital Hannover
Hannover, Germany
Norway
Haukeland University Hospital
Bergen, Norway, 5021

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Peter Hillemanns, MD, PhD

University Hospital Hannover

More Information

No publications provided

Responsible Party:	PhotoCure
ClinicalTrials.gov Identifier:	NCT01256424 History of Changes
Other Study ID Numbers:	PC CE203/10
Study First Received:	December 7, 2010
Last Updated:	October 24, 2012
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Czech Republic: State Institute for Drug Control Slovakia: State Institute for Drug Control Norway: Norwegian Medicines Agency

Keywords provided by PhotoCure:

CIN

Additional relevant MeSH terms:

Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ

Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on June 18, 2013