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Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00060268
First received: May 6, 2003
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  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 1
Phase 2

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:

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:
    Drug: HPPH
    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 May 16, 2013