Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00060268

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Drug: HPPH	Phase I Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Enrollment:	11
Study Start Date:	January 1997
Study Completion Date:	June 2004
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Intervention Details:

iv

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060268

Locations

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Study Chair:

Hector R. Nava, MD, FACS

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Hector Nava, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00060268 History of Changes
Other Study ID Numbers:	CDR0000301589, RPCI-DS-9701
Study First Received:	May 6, 2003
Last Updated:	March 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:

recurrent esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012