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Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Primary Purpose

Cervical Intraepithelial Neoplasia

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Hexaminolevulinate (HAL)

Placebo

Hexaminolevulinate (HAL)

Placebo

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring Cervical intraepithelial neoplasia (CIN)

Eligibility Criteria

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

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.

Sites / Locations

Department of Obstetrics and Gyneacology, Lille University Hospital
Department of Obstetrics and Gynecology
Fritzøe klinikk
Department of Obstetrics and Gynaecology, Ullevål University Hospital
Medicus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Active Comparator

Placebo Comparator

Arm Label

Arm Description

HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)

Placebo suppository (single administration), laser illumination (50J/cm2)

HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)

Placebo ointment (single administration), no illumination

Outcomes

Primary Outcome Measures

Complete Response Rate

Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.

Secondary Outcome Measures

Eradication of HPV

High risk HPV

Incidence of Patients With Adverse Events

Full Information

NCT ID

NCT00708942

First Posted

July 1, 2008

Last Updated

April 17, 2013

Sponsor

Photocure

1. Study Identification

Unique Protocol Identification Number

NCT00708942

Brief Title

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Photocure

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia

Keywords

Cervical intraepithelial neoplasia (CIN)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo suppository (single administration), laser illumination (50J/cm2)

Arm Title

Arm Type

No Intervention

Arm Title

Arm Type

Active Comparator

Arm Description

HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo ointment (single administration), no illumination

Intervention Type

Drug

Intervention Name(s)

Hexaminolevulinate (HAL)

Intervention Description

Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo suppository, for 3-7 hours application

Intervention Type

Drug

Intervention Name(s)

Hexaminolevulinate (HAL)

Intervention Description

Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo ointment for 5 hours application

Primary Outcome Measure Information:

Title

Complete Response Rate

Description

Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Eradication of HPV

Description

High risk HPV

Time Frame

6 months

Title

Incidence of Patients With Adverse Events

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Hillemanns, MD, PhD

Organizational Affiliation

Medizinische Hochschule Hannover, Hannover, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gyneacology, Lille University Hospital

City

Lille

Country

France

Facility Name

Department of Obstetrics and Gynecology

City

Hannover

Country

Germany

Facility Name

Fritzøe klinikk

City

Larvik

Country

Norway

Facility Name

Department of Obstetrics and Gynaecology, Ullevål University Hospital

City

Oslo

Country

Norway

Facility Name

Medicus

City

Trondheim

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

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