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

NCT01256424 | Completed Phase 2 Results

• 1 other identifier: PC CE203/10
• Study Type: interventional
• Target: 262
• Locations: 2 countries
• Sites: 2

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).

Conditions

Cervical Intraepithelial Neoplasia

Keywords

CIN

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after last treatment

Secondary Outcomes (1)

• Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.

  3 months after treatment

Study Arms (4)

HAL 5% with illumination

EXPERIMENTAL

HAL PDT 5%

Drug: HAL 5% with illumination

HAL 1% with illumination

EXPERIMENTAL

HAL PDT 1%

Drug: HAL 1% with illumination

HAL 0.2% with illumination

EXPERIMENTAL

HAL PDT 0.2%

Drug: HAL 0.2% with illumination

Placebo ointment without illumination

PLACEBO COMPARATOR

Placebo without illumination

Drug: Placebo ointment without illumination

Interventions

HAL 5% with illumination DRUG

Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation

HAL 5% with illumination

HAL 1% with illumination DRUG

Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation

HAL 1% with illumination

HAL 0.2% with illumination DRUG

Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation

HAL 0.2% with illumination

Placebo ointment without illumination DRUG

Treatment with a singe dose of 2g placebo ointment, no photoactivation

Placebo ointment without illumination

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Photocure: lead

Study Sites (2)

University Hospital Hannover

Hanover, Germany

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 25467012 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Lighting

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

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Results Point of Contact

• Title: Vice President Research and Development
• Organization: Photocure

ifh@photocure.no

+47 22062210

Study Officials

• Peter Hillemanns, MD, PhD

  University Hospital Hannover

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: December 7, 2010
• First Posted: December 8, 2010
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 16, 2016
• Results First Posted: August 21, 2014

Record last verified: 2016-04

Locations

NO (1); DE (1)