Expired Study
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Buffalo, New York 14263


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.


Study summary:

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.


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)


Study is Available At:


Original ID:

CDR0000301589


NCT ID:

NCT00060268


Secondary ID:

RPCI-DS-9701


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Roswell Park Cancer Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Prim


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:Hector R. Nava, MD, FACS
Study Chair
Roswell Park Cancer Institute

Study Dates

Start Date:January 1997
Completion Date:June 2004
Completion Type:Actual
Primary Completion Date:September 2003
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 7, 2011
First Received Date:May 6, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:HPPH
Description:iv

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Roswell Park Cancer Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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