Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

NCT00978081 | Completed Phase 1

• 3 other identifiers: CDR0000650536UPCC-18308IRB #809093
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

Conditions

Head and Neck Cancer; Precancerous Condition

Keywords

precancerous condition; stage 0 hypopharyngeal cancer; stage 0 laryngeal cancer; stage 0 lip and oral cavity cancer; stage 0 nasopharyngeal cancer; stage 0 oropharyngeal cancer; stage 0 paranasal sinus and nasal cavity cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

  One year

• Maximum tolerated dose

  90 days

Secondary Outcomes (3)

• Response rate

  One year

• Duration of response

  One year

• Time to progression

  2 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.

Drug: aminolevulinic acid hydrochloride

Arm II

EXPERIMENTAL

Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

Drug: aminolevulinic acid hydrochloride

Interventions

aminolevulinic acid hydrochloride DRUG

Patients undergo continuous or fractionated photodynamic therapy.

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following within the past 3 months: * Erythroplakia with dysplasia * Severe dysplasia * Carcinoma in situ of the head and neck for which standard therapy is not indicated, according to any of the following: * Medical condition that precludes surgery * Lesions that cannot be completely resected based on size or location * Significant functional morbidity would be anticipated with further surgery * Refused standard therapy after the treatment has been discussed and offered * No invasive squamous cell carcinoma of the head and neck PATIENT CHARACTERISTICS: * ECOG performance status of 0-2 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST or ALT ≤ 2 times ULN * Alkaline phosphatase ≤ 2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior chronic liver disease or cirrhosis of the liver * No porphyria or hypersensitivity to porphyrins * No significant cardiovascular history that, in the opinion of a cardiologist, would deem the patient at risk for hypotension that may occur with oral administration of aminolevulinic acid (Levulan®) * No prior adverse reaction to ondansetron or lorazepam PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Head and Neck Neoplasms; Precancerous Conditions; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Mouth Diseases; Nasopharyngeal Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Ahn, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

US (1)