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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT01256424
First received: December 7, 2010
Last updated: August 21, 2014
Last verified: August 2014
  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: HAL 5% with illumination
Drug: HAL 1% with illumination
Drug: HAL 0.2% with illumination
Drug: Placebo ointment without illumination
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:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Comparison of 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 ]
    Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.


Secondary Outcome Measures:
  • Comparison of 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: No ]
    HPV response was defined as clearance of baseline HPV infection, asssessed by genotype


Enrollment: 262
Study Start Date: April 2011
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: HAL 5% with illumination
Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
Experimental: HAL 1% with illumination
HAL PDT 1%
Drug: HAL 1% with illumination
Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
Experimental: HAL 0.2% with illumination
HAL PDT 0.2%
Drug: HAL 0.2% with illumination
Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
Placebo Comparator: Placebo ointment without illumination
Placebo without illumination
Drug: Placebo ointment without illumination
Treatment with a singe dose of 2g placebo ointment, no 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: August 6, 2014
Last Updated: August 21, 2014
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:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 21, 2014