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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

November 23, 2009
November 6, 2014
January 2009
November 2014   (final data collection date for primary outcome measure)
PDT related toxicity.
Same as current
Complete list of historical versions of study NCT01019954 on ClinicalTrials.gov Archive Site
lesion response.
Same as current
Not Provided
Not Provided
 
Photodynamic Therapy for Early Head and Neck Tumors
Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Head and Neck Tumors
Drug: Levulan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01019954
UPCC 18308
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP