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

NCT00670397 — Phase 1, Terminated, 11 participants, Roswell Park Cancer Institute

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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

Registry	NCT00670397
Status	Terminated - safety issues
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	11 (Actual)
Sponsor	Roswell Park Cancer Institute (Other)
Conditions	Head and Neck Cancer
Interventions	HPPH (Drug)
Dates	start 2010-06-01, primary completion 2011-11-01, completion 2015-07-01, first posted 2008-05-01, last updated 2016-03-16
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment (PDT)	Experimental	Drug: HPPH	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.

HPPH (Drug): IV

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to 120 Years

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

+Locations (1)

Facility	City	Country	Status
Roswell Park Cancer Institute	Buffalo, New York	United States

+Investigators

Hassan Arshad, MD, Principal investigator, Roswell Park Cancer Institute