A Phase 1a Trial of Photodynamic Therapy with HPPH (2-1[hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the oral Cavity and Oropharynx
Title A Phase 1a Trial of Photodynamic Therapy with HPPH (2-1[hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the oral Cavity and Oropharynx
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Principal Investigator Nestor Rigual, MD
Study Number 170910
Phase1
Summary Patients will receive HPPH (photosensitizer drug) IVPB over one hour. Twenty-four hours (22-26 hours from start of HPPH) patients will receive laser light application. Sunlight precautions are maintained for 1-2 weeks from the day of the HPPH infusion. The patients may have retreatment at least 6 weeks after the first treatment if needed.
Eligibility
- Patients with moderate to severe dysplasia, squamous cell carcinoma-in-situ and/or T1 squamous cell carcinoma of the oral cavity and/or oropharynx, primary or recurrent.
Exclusion Criteria:
- True tongue base lesions (as determined by the treating physician)
- Patients with severe trismus that prevents adequate access to the lesion for treatment light delivery (as determined by the treating physician).
- Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- Patients with impaired hepatic or minimal impairment of renal function (total serum bilirubin > 2.0 mg/d, serum creatinine > 2.0 mg/d), alkaline phosphatase (hepatic) or SGOT > 3 times the upper normal limit.
