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CompletedNCT00281736Updated Jan 3, 2014

Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer

A Phase 2 interventional study of HPPH in Esophageal Cancer and Precancerous Condition, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-03.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be effective in killing precancerous cells and tumor cells.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer.

Read the detailed description

OBJECTIVES:

  • Determine response in patients with high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus and Barrett's esophagus treated with photodynamic therapy using HPPH.
  • Determine the safety, in terms of toxicity to surrounding normal tissue, of this regimen in these patients.
  • Determine the toxic effects of this regimen on surrounding normal tissue in these patients.
  • Determine the incidence of adenocarcinoma in these patients after this treatment.
  • Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen.
  • Determine the minimal erythemal dose of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to presence of intramucosal tumor (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
  • Arm II: Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study within 3 years.

02

Conditions studied

  • Esophageal Cancer
  • Precancerous Condition

Keywords

  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • stage 0 esophageal cancer
  • stage I esophageal cancer
  • precancerous condition
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus

    • Stage 0 or N0, M0 primary or recurrent disease
  • Diagnosis of Barrett's esophagus
  • Ineligible for or refused surgical resection
  • Requires endoscopy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 4,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • PT ≤ 1.5 times upper limit of normal (ULN)

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 3 times ULN
  • ALT ≤ 3 times ULN

Renal

  • Creatinine ≤ 2 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No contraindication to endoscopy
  • No other malignancy except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free
  • No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • At least 1 month since prior chemotherapy
  • No concurrent chemotherapy

Radiotherapy

  • At least 1 month since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 1 month since prior Nd-YAG laser therapy
  • At least 4 weeks since prior therapy for this disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Arm I

    Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.

    Drug: HPPH

  • Experimental
    Arm II

    Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

    Drug: HPPH

Interventions

  • DrugHPPH

    Given IV

06

What researchers measure

Primary outcomes

  1. Efficacy

    Time frame: 3 years

Secondary outcomes

  1. Toxicity

    Time frame: 3 years

  2. Response

    Time frame: 3 years

07

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00281736
Lead sponsor
Roswell Park Cancer Institute
Responsible party
Sponsor
First posted
Jan 25, 2006
Start date
Feb 2004
Primary completion
Jul 2007
Completion
Dec 2013
Last update
Jan 3, 2014

Study contacts

Hector R. Nava, MD, FACS
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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