Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments hpph, laser therapy
Phase phase 1
Sponsor Roswell Park Cancer Institute
Start date January 2008
End date November 2015
Trial size 29 participants
Trial identifier NCT00675233, CDR0000595166, RPCI-I-119207

Summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light to the tumor on day 2. At least 6 weeks later, patients achieving partial response, no response, or a geographical miss may undergo a second course of treatment.
hpph
Given IV
laser therapy
Escalating light doses with 665 nm light

Primary Outcomes

Measure
Toxicity
time frame: 6 weeks
Tumor response
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Biopsy-confirmed diagnosis of 1 of the following: - Mild to severe dysplasia of the larynx - Dysplastic lesions > 3 mm in thickness - Squamous cell carcinoma in situ of the larynx - T1 squamous cell carcinoma of the larynx - Tumor > 3 mm in thickness - No T2-T4 squamous cell carcinoma of the larynx - Newly diagnosed or recurrent disease PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Total bilirubin > 2.0 mg/dL - Creatinine > 2.0 mg/dL - SGOT > 3 times upper limit of normal (ULN) - Alkaline phosphatase > 3 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment - No porphyria - No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: - Any prior therapy allowed - At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Additional Information

Official title Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx
Principal investigator Hassan Arshad, MD
Description OBJECTIVES: Primary - To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx. Secondary - To determine response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of laser light therapy. Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Roswell Park Cancer Institute.