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Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060268
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : March 9, 2011
Information provided by:
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: HPPH Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
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)
Study Start Date : January 1997
Actual Primary Completion Date : September 2003
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: HPPH

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • WBC at least 2,000/mm^3
  • Platelet count at least 50,000/mm^3


  • 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


  • Creatinine no greater than 3.0 mg/dL


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to endoscopy
  • No porphyria
  • No hypersensitivity to porphyrins


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060268

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Study Chair: Hector R. Nava, MD, FACS Roswell Park Cancer Institute
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Responsible Party: Hector Nava, MD, Roswell Park Cancer Institute Identifier: NCT00060268    
Other Study ID Numbers: CDR0000301589
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2011
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:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases