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

NCT00708942 | Terminated Phase 2 Results

• 1 other identifier: PC CE201/08
• Study Type: interventional
• Target: 83
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical intraepithelial neoplasia (CIN)

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

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

  6 month

Secondary Outcomes (2)

• Eradication of HPV

  6 months

• Incidence of Patients With Adverse Events

  3 months

Study Arms (5)

1

ACTIVE COMPARATOR

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

Drug: Hexaminolevulinate (HAL)

2

PLACEBO COMPARATOR

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

Drug: Placebo

3

NO INTERVENTION

4

ACTIVE COMPARATOR

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

Drug: Hexaminolevulinate (HAL)

5

PLACEBO COMPARATOR

Placebo ointment (single administration), no illumination

Drug: Placebo

Interventions

Hexaminolevulinate (HAL) DRUG

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

1

Placebo DRUG

Placebo suppository, for 3-7 hours application

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Photocure: lead

Study Sites (5)

Department of Obstetrics and Gyneacology, Lille University Hospital

Lille, France

Location

Department of Obstetrics and Gynecology

Hanover, Germany

Location

Fritzøe klinikk

Larvik, Norway

Location

Department of Obstetrics and Gynaecology, Ullevål University Hospital

Oslo, Norway

Location

Medicus

Trondheim, Norway

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

Slow recruitment lead to early terminaiton of the second part of the trial, including arms 4 and 5, after enrolment of 13 patients. No formal statistical analysis conducted on this part of the data.

Results Point of Contact

• Title: Bjørn Klem, Project Director
• Organization: Photocure

bk@photocure.no

+47 22 06 22 10

Study Officials

• Peter Hillemanns, MD, PhD

  Medizinische Hochschule Hannover, Hannover, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 24, 2013
• Results First Posted: April 15, 2013

Record last verified: 2013-04

Locations

NO (3); FR (1); DE (1)