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
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
Contact MICOOP
Principal Investigator Nestor Rigual, MD
Study Number 119207
Phase1
Summary Patients with moderate to severe dysplasia, squamous carcinoma in situ and/or T1 squamous cell carcinoma of the larynx (newly diagnosed or recurrent squamous cell carcinoma of the larynx) will be eligible for this study. Patients will receive HPPH 4.0 mg/m2 infusion over 1 h. Approximately 24 (22-26)h later they will receive 665 nm light. The light dose will be escalated from a starting light dose of 50 J/cm2 to 75 J/cm 2, 100 J/cm2, 125 J/cm2 and 150 J/cm2.
Eligibility
- Patients with moderate to severe dysplasia, squamous carcinoma-in situ and/or T1 squamous cell carcinoma of the larynx
- Patients with newly diagnosed or recurrent squamous cell carcinoma of the larynx
- Diagnosis will be confirmed by biopsy
- Prior therapy of any type is allowed
- Male or female patients at least 18 years old. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal. Male patients should be using a medically acceptable form of birth control or be sterile.
- Must have ECOG status of 0-2
