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

Primary Purpose

Esophageal Cancer, Precancerous Condition

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HPPH
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, recurrent esophageal cancer, stage 0 esophageal cancer, stage I esophageal cancer, precancerous condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Toxicity
Response

Full Information

First Posted
January 24, 2006
Last Updated
December 31, 2013
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00281736
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Precancerous Condition
Keywords
adenocarcinoma of the esophagus, recurrent esophageal cancer, stage 0 esophageal cancer, stage I esophageal cancer, precancerous condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.
Intervention Type
Drug
Intervention Name(s)
HPPH
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
3 years
Title
Response
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector R. Nava, MD, FACS
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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