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Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and Stage I Carcinoma of the Oral Cavity


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and Stage I Carcinoma of the Oral Cavity


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Nestor R. Rigual, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 109307

NCT ID:

NCT00670397

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage I squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage 0 lip and oral cavity cancer
  • Carcinoma
  • Carcinoma in Situ
  • Head and Neck Neoplasms
  • Mouth Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263