Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer

NCT00670397 | Terminated Phase 1 DMC

• 2 other identifiers: I 109307RPCI-I-109307
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Evidence of dose limiting Toxicities (DLT)

  Each cohort of 3 patients will be observed for the first 4 weeks to monitor for DLT.

  First four weeks

• Tumor response

  3 months

Study Arms (1)

Treatment (PDT)

EXPERIMENTAL

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

Interventions

HPPH DRUG

IV

Treatment (PDT)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hassan Arshad, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 1, 2008
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)