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

NCT ID: NCT00281736

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2013-12-31

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.

Conditions

Esophageal Cancer; Precancerous Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

Given IV

Arm II

Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

Given IV

Interventions

HPPH

Given IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hector R. Nava, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

I 30404

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000441205

Identifier Type: -

Identifier Source: org_study_id