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

This study has been suspended.

Sponsored by: Roswell Park Cancer Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00281736
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Precancerous/Nonmalignant Condition
Drug: HPPH
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Response [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   February 2004
Estimated Primary Completion Date:   July 2009 (Final data collection date for primary outcome measure)

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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281736

Locations
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators
Roswell Park Cancer Institute

Investigators
Principal Investigator:     Hector R. Nava, MD, FACS     Roswell Park Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000441205, RPCI-I-30404
First Received:   January 24, 2006
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00281736
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus  
recurrent esophageal cancer  
stage 0 esophageal cancer  
stage I esophageal cancer  
precancerous/nonmalignant condition  

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Precancerous Conditions
Gastrointestinal Diseases
Esophageal Neoplasms
Recurrence
Carcinoma
Digestive System Diseases
Carcinoma in Situ
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




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