Clinical trial NCT00281736: Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
Official title: A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Precancerous Condition
Keywords: adenocarcinoma of the esophagus
recurrent esophageal cancer
stage 0 esophageal cancer
stage I esophageal cancer
precancerous condition
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2006-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, and kills tumor cells. HPPH may be effective in killing precancerous cells and tumor cells.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer.

Detailed description: OBJECTIVES:

* Determine response in patients with high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus and Barrett's esophagus treated with photodynamic therapy using HPPH.
* Determine the safety, in terms of toxicity to surrounding normal tissue, of this regimen in these patients.
* Determine the toxic effects of this regimen on surrounding normal tissue in these patients.
* Determine the incidence of adenocarcinoma in these patients after this treatment.
* Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen.
* Determine the minimal erythemal dose of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to presence of intramucosal tumor (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
* Arm II: Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study within 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus

  * Stage 0 or N0, M0 primary or recurrent disease
* Diagnosis of Barrett's esophagus
* Ineligible for or refused surgical resection
* Requires endoscopy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 50-100%

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 4,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* PT ≤ 1.5 times upper limit of normal (ULN)

Hepatic

* Bilirubin ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times ULN
* ALT ≤ 3 times ULN

Renal

* Creatinine ≤ 2 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No contraindication to endoscopy
* No other malignancy except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free
* No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

Chemotherapy

* At least 1 month since prior chemotherapy
* No concurrent chemotherapy

Radiotherapy

* At least 1 month since prior radiotherapy
* No concurrent radiotherapy

Surgery

* See Disease Characteristics

Other

* At least 1 month since prior Nd-YAG laser therapy
* At least 4 weeks since prior therapy for this disease

Primary outcomes:
measure: Efficacy
timeFrame: 3 years
Secondary outcomes:
measure: Toxicity
timeFrame: 3 years
measure: Response
timeFrame: 3 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Hector R. Nava, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: