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Photodynamic Therapy for Early Head and Neck Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01019954
First received: November 23, 2009
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

This is a study to evaluate the safety and find the highest tolerable dose of Levulan® and Photodynamic Therapy (PDT) for premalignant tumors of the head and neck. Subjects will receive Levulan® by mouth and will undergo PDT. Levulan® goes throughout the body, but gets retained in cancer cells more than non-cancer cells. After 4-6 hours, the targeted area is treated with laser light which activates the Levulan® to kill the cells that contain it.


Condition Intervention Phase
Head and Neck Tumors
Drug: Levulan
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • PDT related toxicity.

Secondary Outcome Measures:
  • lesion response.

Estimated Enrollment: 48
Study Start Date: January 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Overall Objectives:

The primary objectives of the study are to evaluate the toxicities associated with Levulan®-mediated photodynamic therapy in pre-malignant head and neck lesions, and to evaluate the toxicities of continuous vs. fractionated light treatment. The secondary objectives are to assess the efficacy of Levulan®-mediated photodynamic therapy in pre-malignant head and neck lesions, and to assess the efficacy of fractionated versus continuous light treatment.

  Eligibility

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

Inclusion Criteria:

  • Study subjects with a histologic diagnosis of erythroplakia with dysplasia, severe dysplasia, or carcinoma in-situ of the head and neck. Study subjects with carcinoma in-situ will be eligible only in situations where standard therapy is not indicated.
  • ECOG performance status of 0-2.
  • Males and females 18 years of age or older.
  • Study subjects capable of providing informed consent indicating an understanding of the potential risks, benefits and complications of the proposed treatment.
  • Premalignant lesions but where the final pathologic evaluation notes a suspicion or the presence of focal microinvasion but where the predominant lesion is premalignant.
  • Clinical assessment of the depth of the lesion which confirms that the lesion's clinical depth is consistent with the pathologic evaluation that identifies the suspicion or the presence of only focal microinvasion.
  • Agreement with the treating surgeon that the suspicion or the presence of focal microinvasion can be treated without surgical resection.

Exclusion Criteria:

  • Study subjects in whom the targeted lesion/area has invasive squamous cell carcinoma of the head and neck greater than 1.5 mm from the tissue surface.
  • Study subjects with invasive squamous cell carcinoma of the head and neck.
  • Study subjects who are pregnant or lactating.
  • Study subjects who have a platelet count of less than 100,000/cubic mm.
  • Study subjects who refuse to provide informed consent (see 3.4).
  • 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.
  • Study subjects with a significant cardiovascular history such that an evaluation by a cardiologist deems the study subject to be at risk with the hypotension that may occur with oral administration of Levulan® .
  • Study subjects with porphyria or hypersensitivity to porphyrins.
  • Study subjects who have had an adverse reaction to ondansetron or lorazepam.
  • Study subjects who have an 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 and also include subjects with HIV infection.
  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: NCT01019954

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01019954     History of Changes
Other Study ID Numbers: UPCC 18308
Study First Received: November 23, 2009
Last Updated: November 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Adults with premalignant head and neck tumors and adults who have Carcinoma in situ of the head and neck in whom standard therapy is not indicated

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 27, 2014