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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01256424
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : August 21, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Description
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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).

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : April 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. [ Time Frame: 3 months after treatment ]
    HPV response was defined as clearance of baseline HPV infection, asssessed by genotype


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256424


Locations
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Germany
University Hospital Hannover
Hannover, Germany
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Photocure
Investigators
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Principal Investigator: Peter Hillemanns, MD, PhD University Hospital Hannover
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT01256424    
Other Study ID Numbers: PC CE203/10
First Posted: December 8, 2010    Key Record Dates
Results First Posted: August 21, 2014
Last Update Posted: May 16, 2016
Last Verified: April 2016
Keywords provided by Photocure:
CIN
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
 Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases