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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HAL 5% with illumination
HAL 1% with illumination
HAL 0.2% with illumination
Placebo ointment without illumination
Sponsored by
Photocure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring CIN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Hannover
  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

HAL 5% with illumination

HAL 1% with illumination

HAL 0.2% with illumination

Placebo ointment without illumination

Arm Description

HAL PDT 5%

HAL PDT 1%

HAL PDT 0.2%

Placebo without illumination

Outcomes

Primary Outcome Measures

Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After 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

Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
HPV response was defined as clearance of baseline HPV infection, asssessed by genotype

Full Information

First Posted
December 7, 2010
Last Updated
April 8, 2016
Sponsor
Photocure
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1. Study Identification

Unique Protocol Identification Number
NCT01256424
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photocure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
CIN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAL 5% with illumination
Arm Type
Experimental
Arm Description
HAL PDT 5%
Arm Title
HAL 1% with illumination
Arm Type
Experimental
Arm Description
HAL PDT 1%
Arm Title
HAL 0.2% with illumination
Arm Type
Experimental
Arm Description
HAL PDT 0.2%
Arm Title
Placebo ointment without illumination
Arm Type
Placebo Comparator
Arm Description
Placebo without illumination
Intervention Type
Drug
Intervention Name(s)
HAL 5% with illumination
Intervention Description
Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
Intervention Type
Drug
Intervention Name(s)
HAL 1% with illumination
Intervention Description
Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
Intervention Type
Drug
Intervention Name(s)
HAL 0.2% with illumination
Intervention Description
Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
Intervention Type
Drug
Intervention Name(s)
Placebo ointment without illumination
Intervention Description
Treatment with a singe dose of 2g placebo ointment, no photoactivation
Primary Outcome Measure Information:
Title
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
Description
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.
Time Frame
3 months after last treatment
Secondary Outcome Measure Information:
Title
Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
Description
HPV response was defined as clearance of baseline HPV infection, asssessed by genotype
Time Frame
3 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hillemanns, MD, PhD
Organizational Affiliation
University Hospital Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hannover
City
Hannover
Country
Germany
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25467012
Citation
Hillemanns P, Garcia F, Petry KU, Dvorak V, Sadovsky O, Iversen OE, Einstein MH. A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2. Am J Obstet Gynecol. 2015 Apr;212(4):465.e1-7. doi: 10.1016/j.ajog.2014.10.1107. Epub 2014 Oct 31.
Results Reference
derived

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

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