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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2012

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.

Interventions

  • Drug: Hexaminolevulinate (HAL)
    • Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
  • Drug: Placebo
    • Placebo suppository, for 3-7 hours application
  • Drug: Hexaminolevulinate (HAL)
    • Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
  • Drug: Placebo
    • Placebo ointment for 5 hours application

Arms, Groups and Cohorts

  • Active Comparator: 1
    • HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
  • Placebo Comparator: 2
    • Placebo suppository (single administration), laser illumination (50J/cm2)
  • No Intervention: 3
  • Active Comparator: 4
    • HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)
  • Placebo Comparator: 5
    • Placebo ointment (single administration), no illumination

Clinical Trial Outcome Measures

Primary Measures

  • Complete Response Rate
    • Time Frame: 6 month
    • Based on histology, cytology and HPV status. “Complete response” is defined as normal pathology, normal cytology and negative HPV.

Secondary Measures

  • Eradication of HPV
    • Time Frame: 6 months
    • High risk HPV
  • Incidence of Patients With Adverse Events
    • Time Frame: 3 months

Participating in This Clinical Trial

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.
  • Gender Eligibility: Female

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Photocure
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Peter Hillemanns, MD, PhD, Principal Investigator, Medizinische Hochschule Hannover, Hannover, Germany

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.