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A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

This study has been completed.
Sponsor:
Information provided by:
PhotoCure
ClinicalTrials.gov Identifier:
NCT00369018
First received: August 28, 2006
Last updated: November 26, 2010
Last verified: November 2010
  Purpose

The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).


Condition Intervention Phase
Cervical Dysplasia
Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

Resource links provided by NLM:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Lesion eradication [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Eradication of lesion and HPV [ Time Frame: 6 and 12 months ]
  • Safety assessment [ Time Frame: 6 months ]

Estimated Enrollment: 96
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MAL 3 Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: MAL 12 Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 10, 3 Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 10, 12 Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 40, 3 Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Active Comparator: HAL 40, 12 Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

Detailed Description:

Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.

This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive histology of CIN 1-3

Exclusion Criteria:

  • Patients with endocervical lesions
  • Patients with AGUS
  • Patients with invasive disease
  • Patients with porphyria
  • Patients sensitive to MAL and HAL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369018

Locations
Germany
Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
Hannover, Germany, 30625
Norway
Ullevål University Hospital, Department of Obstetrics and Gynecology
Oslo, Norway, 0407
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Peter Hillemanns, Md PhD Hannover Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00369018     History of Changes
Other Study ID Numbers: PC CE101/06
Study First Received: August 28, 2006
Last Updated: November 26, 2010
Health Authority: Norway: Norwegian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PhotoCure:
photodynamic therapy
methyl aminolevulinate
hexaminolevulinate
dose-finding
cervical dysplasia

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma
Carcinoma in Situ
Genital Diseases, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014