Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281736
• Other study ID #: CDR0000441205
• Secondary ID: I 30404
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: December 31, 2013
• Start date: February 2004
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Esophageal Cancer
• Esophageal Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Drug:
• HPPH
Given IV

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		3 years	No
Secondary	Toxicity		3 years	Yes
Secondary	Response		3 years	No