NCT00060268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 9, 2011

Status Verified

March 1, 2011

Enrollment Period

6.7 years

First QC Date

May 6, 2003

Last Update Submit

March 7, 2011

Conditions

Esophageal Cancer

Keywords

recurrent esophageal cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancer

Interventions

HPPHDRUG

iv

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Hector R. Nava, MD, FACS

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

January 1, 1997

Primary Completion

September 1, 2003

Study Completion

June 1, 2004

Last Updated

March 9, 2011

Record last verified: 2011-03

Locations

US(1)