Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1 - Full Text View

Sponsor:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00708942

Purpose

The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Condition	Intervention	Phase
Cervical Intraepithelial Neoplasia	Drug: Hexaminolevulinate (HAL) Drug: Placebo	Phase II

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 Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluoxymesterone Hexyl 5-aminolevulinate

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:

Lesion eradication [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Eradication of lesion and HPV [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 HAL suppository, laser illumination	Drug: Hexaminolevulinate (HAL) Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
Placebo Comparator: 2 Placebo suppository, laser illumination	Drug: Placebo Placebo suppository, for 3-7 hours application
No Intervention: 3
Active Comparator: 4 HAL ointment, LED diode illumination	Drug: Hexaminolevulinate (HAL) Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
Placebo Comparator: 5 Placebo ointment, no illumination	Drug: Placebo Placebo ointment for 5 hours application

Detailed Description:

Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.

In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.

Eligibility

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

Criteria

Inclusion Criteria:

Satisfactory colposcopy examination
Negative endocervical canal by colposcopy
Ectocervical CIN1 as verified by local pathologist (biopsy).
Colposcopical visible lesion at visit 2, before photoactivation
Written Informed Consent signed
Age 18 or above

Exclusion Criteria:

Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
Malignant cells on cytology or histology
Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
Suspicion of endocervical disease on colposcopy
Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination
Known or suspected porphyria
Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
Use of heart pacemaker
Pregnancy
Nursing
Childbirth or miscarriage within six weeks of enrolment - Known
Participation in other "competitive" clinical studies either concurrently or within the last 30 days
Risk of poor protocol compliance
Not willing to use adequate birth control from screening until last PDT
Subject 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: NCT00708942

Contacts

Contact: Gudrun Trøite, Ph.D	47-2206-2210	gt@photocure.no
Contact: Bjørn Klem, M.Sc.Pharm	47-2206-2210

Locations

France
Department of Obstetrics and Gyneacology, Lille University Hospital	Recruiting
Lille, France
Contact: Pierre Collinet, MD, PhD
Germany
Department of Obstetrics and Gynecology	Completed
Hannover, Germany
Norway
Fritzøe klinikk	Recruiting
Larvik, Norway
Contact: Tore Lunde, MD
Department of Obstetrics and Gynaecology, Ullevål University Hospital	Completed
Oslo, Norway
Medicus	Recruiting
Trondheim, Norway
Contact: Terje Sørdal

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Peter Hillemanns, MD, PhD

Medizinische Hochschule Hannover, Hannover, Germany

More Information

No publications provided

Responsible Party:	Gudrun Trøite, Photocure
ClinicalTrials.gov Identifier:	NCT00708942 History of Changes
Other Study ID Numbers:	PC CE201/08
Study First Received:	July 1, 2008
Last Updated:	November 26, 2010
Health Authority:	Norway: Norwegian Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; France: Ministry of Health

Keywords provided by PhotoCure:

Cervical intraepithelial neoplasia (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 February 09, 2012