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

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ClinicalTrials.gov Identifier: NCT00708942
Recruitment Status : Terminated (Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study)
First Posted : July 3, 2008
Results First Posted : April 15, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

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

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Drug: Hexaminolevulinate (HAL) Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
Study Start Date : January 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012


Arm Intervention/treatment
Active Comparator: 1
HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
Drug: Hexaminolevulinate (HAL)
Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application

Placebo Comparator: 2
Placebo suppository (single administration), laser illumination (50J/cm2)
Drug: Placebo
Placebo suppository, for 3-7 hours application

No Intervention: 3
Active Comparator: 4
HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)
Drug: Hexaminolevulinate (HAL)
Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application

Placebo Comparator: 5
Placebo ointment (single administration), no illumination
Drug: Placebo
Placebo ointment for 5 hours application




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Eradication of HPV [ Time Frame: 6 months ]
    High risk HPV

  2. Incidence of Patients With Adverse Events [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708942


Locations
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France
Department of Obstetrics and Gyneacology, Lille University Hospital
Lille, France
Germany
Department of Obstetrics and Gynecology
Hannover, Germany
Norway
Fritzøe klinikk
Larvik, Norway
Department of Obstetrics and Gynaecology, Ullevål University Hospital
Oslo, Norway
Medicus
Trondheim, Norway
Sponsors and Collaborators
Photocure
Investigators
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Principal Investigator: Peter Hillemanns, MD, PhD Medizinische Hochschule Hannover, Hannover, Germany
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Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00708942    
Other Study ID Numbers: PC CE201/08
First Posted: July 3, 2008    Key Record Dates
Results First Posted: April 15, 2013
Last Update Posted: April 24, 2013
Last Verified: April 2013
Keywords provided by Photocure:
Cervical intraepithelial neoplasia (CIN)
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents