Photodynamic Therapy for Early Head and Neck Tumors

Head and Neck Tumors Clinical Trial

Official title:

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019954
• Other study ID #: UPCC 18308
• Status: Completed
• Phase: Phase 1
• Start date: January 2009
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Tumors

Intervention

Drug:
• Levulan

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDT related toxicity.
Secondary	lesion response.