Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

NCT00453336 | Completed Phase 2 Results DMC

• 3 other identifiers: 20020618SCCC-2002103WIRB-20050715
• Study Type: interventional
• Target: 45
• 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, precancerous cells and cancer cells are killed. PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

Conditions

Head and Neck Cancer; Precancerous/Nonmalignant Condition

Keywords

recurrent squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; oral leukoplakia

Outcome Measures

Primary Outcomes (2)

• Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment

  Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.

  6 months

• Number of Participants Experiencing Adverse Events

  Number of participants enrolled experiencing serious adverse events and/or other non-serious events

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Porfimer Sodium; Procedure: Photodynamic Therapy

Interventions

Porfimer Sodium DRUG

Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.

Also known as: Photofrin

Single Arm

Photodynamic Therapy PROCEDURE

Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.

Also known as: Microlens Diffuser P/N 5416

Single Arm

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Any of the following benign lesions: * Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant * Carcinoma in situ * Superficial (\< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx * T1-T3 disease * Meets one of the following criteria: * Failed radiation therapy and refused standard salvage surgery * Refused radiation therapy and/or surgery as primary therapy * No good surgical alternative with acceptable morbidity * Condemned mucosa syndrome * At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas PATIENT CHARACTERISTICS: * Creatinine ≤ 2 mg/dL * AST and ALT ≤ 30% elevated * Alkaline phosphatase ≤ 30% elevated * Bilirubin ≤ 1.0 mg/dL * No contraindication to anesthesia or analgesia * No porphyria * No hypersensitivity to porphyrins * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Civantos F. Photodynamic therapy for head and neck lesions in the subtropics. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S65-8. doi: 10.6004/jnccn.2012.0179.

  PMID: 23055220 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Precancerous Conditions; Squamous Cell Carcinoma of Head and Neck; Leukoplakia, Oral

Interventions

Dihematoporphyrin Ether; Photochemotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Leukoplakia; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: Francisco Civantos MD
• Organization: University of Miami Sylvester Comprehensive Cancer Center

fcivanto@med.miami.edu

305-243-5276

Study Officials

• Francisco Civantos, Jr., MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: June 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2010
• Last Updated: February 8, 2017
• Results First Posted: October 18, 2013

Record last verified: 2016-12

Locations

US (1)