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A Phase I Study of Photodynamic Therapy (PDT) for High-grade Anal Dysplasia and Microinvasive Anal Cancer

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ClinicalTrials.gov Identifier: NCT02698293
Recruitment Status : Not yet recruiting
First Posted : March 3, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of patients with pre-malignant tumors and superficial microinvasive disease of the anal canal and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer Gliolan orally followed by the administration of red light (629-635 nm) to the tumor from a laser. The dose of Gliolan will be 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in each. Patients will be observed for 30 days for the development of DLT. Patients will be followed up for 24 months for additional toxicity and efficacy data collection.

Condition or disease Intervention/treatment Phase
Anal Cancer Drug: Gliolan Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Photodynamic Therapy (PDT) for High-grade Anal Dysplasia and Microinvasive Anal Cancer
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 1 Drug: Gliolan
orally, 40 mg/kg
Experimental: Cohort 2 Drug: Gliolan
orally, 40 mg/kg
Experimental: Cohort 3 Drug: Gliolan
orally, 40 mg/kg



Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A histological or cytological diagnosis of high-grade dysplasia or carcinoma in-situ, within past 4 months.
  • Premalignant lesions containing focal microinvasion are eligible when:
  • Surgery is not clinically mandated.
  • Subjects with medical conditions precluding surgery.
  • Subjects whose lesions cannot be completely resected based on size or location, or where significant functional morbidity would be anticipated with further surgery.
  • Patients refuse surgery.
  • The justification for inclusion of patients with microinvasive disease is based reports demonstrating the ability of photodynamic therapy to successfully treat both dysplasia and T1 squamous cell carcinoma of the anal canal (22).
  • ECOG performance status of 0-1.
  • 18 years of age or older.
  • Study subjects capable of providing informed consent.

Exclusion Criteria:

  • Study subjects in whom the lesion has invasive squamous cell carcinoma of the anal cavity which is clinically appreciable.
  • Clinically occult microinvasive squamous cell carcinoma of the anal cavity which is not focal.
  • Study subjects who are pregnant or lactating.
  • Study subjects who have a platelet count of less than 100,000/cubic mm.
  • Study subjects with elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin levels >2X normal or a history of chronic liver disease or cirrhosis of the liver.
  • Significant cardiovascular history that would put the study subject at risk from hypotension that may occur with Gliolan
  • Study subjects with porphyria or hypersensitivity to porphyrins.
  • Study subjects with abnormal baseline creatinine level or diagnosed kidney disease.
  • Study subjects who have a medical history of immune suppression. This will include patients with a past transplantation requiring ongoing immunosuppressive medications. Patients with HIV infection are eligible provided they are on highly active anti-retroviral therapy and their most recent CD4 count is >200

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): NCT02698293


Contacts
Contact: Sally McNulty, RN 215-662-7720 Sally.McNulty@uphs.upenn.edu

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sally McNulty, RN    215-662-7720    sally.mcnulty@uphs.upenn.edu   
Principal Investigator: Edgar Ben-Josef, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Edgar Ben-Josef, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02698293     History of Changes
Other Study ID Numbers: UPCC 08216
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases