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Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPPH
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring recurrent esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed esophageal cancer Stages T1-T3, any N, any M Tumor partially or completely obstructing the esophagus Primary or recurrent tumor meeting 1 of the following criteria for treatment: Patient is too debilitated for or refused conventional therapy Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site No tracheal or bronchial involvement by bronchoscopy No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic Bilirubin no greater than 3.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN PT no greater than 1.5 times ULN Renal Creatinine no greater than 3.0 mg/dL Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No contraindications to endoscopy No porphyria No hypersensitivity to porphyrins PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
March 7, 2011
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00060268
Brief Title
Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
Official Title
A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.
Detailed Description
OBJECTIVES: Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy. Determine, preliminarily, tumor response in patients treated with this drug. Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients. Determine plasma clearance rates for this drug in these patients. OUTLINE: This is a dose-escalation study. Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2. Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity. Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months. PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
recurrent esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HPPH
Intervention Description
iv

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed esophageal cancer Stages T1-T3, any N, any M Tumor partially or completely obstructing the esophagus Primary or recurrent tumor meeting 1 of the following criteria for treatment: Patient is too debilitated for or refused conventional therapy Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site No tracheal or bronchial involvement by bronchoscopy No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic Bilirubin no greater than 3.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN PT no greater than 1.5 times ULN Renal Creatinine no greater than 3.0 mg/dL Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No contraindications to endoscopy No porphyria No hypersensitivity to porphyrins PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector R. Nava, MD, FACS
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
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 Using HPPH in Treating Patients With Obstructive Esophageal Tumors

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