Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage I oral cavity cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose in the oral cavity of photodynamic therapy (PDT) using HPPH and 665 nm light in patients with recurrent dysplasia, carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity.
Secondary
- To determine response of dysplasia, carcinoma in situ, and selected patients with T1 squamous cell carcinoma of the oral cavity using PDT with HPPH and 665 nm light.
OUTLINE: This is a dose-escalation study of laser light dose therapy.
Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours after receiving HPPH, patients undergo laser light treatment to the tumor bed on day 2. Patients with multicentric or large area confluent disease receive a second course of treatment at least 8 weeks later for lesions untreated at the first treatment session.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and periodically thereafter.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (PDT) Patients undergo PDT comprising HPPH IV over 1 hour on day 1 followed by laser light treatment to the tumor bed on day 2. Treatment may repeat every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. |
Drug: HPPH
IV
|
Outcome Measures
Primary Outcome Measures
- Evidence of dose limiting Toxicities (DLT) [First four weeks]
Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.
- Tumor response [3 months]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Biopsy-confirmed diagnosis of 1 of the following:
-
Mild to severe dysplasia
-
Carcinoma in situ (CIS) of the oral cavity
-
Carcinoma must be less than 3mm thick
-
Stage I (T1) squamous cell carcinoma of the oral cavity
-
Recurrent or primary disease
-
No T2 or greater squamous cell carcinoma, exophytic CIS, or dysplasia lesions
PATIENT CHARACTERISTICS:
-
ECOG performance status 0-2
-
Total bilirubin ≤ 2.0 mg/dL
-
Creatinine ≤ 2.0 mg/dL
-
Alkaline phosphatase ≤ 3 times the upper limit of normal (ULN)
-
SGOT ≤ 3 times ULN
-
Not pregnant
-
Fertile patients must use effective contraception
-
No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
PRIOR CONCURRENT THERAPY:
-
Prior therapy of any type allowed
-
More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
Investigators
- Principal Investigator: Hassan Arshad, MD, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I 109307
- RPCI-I-109307