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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00281736
First received: January 24, 2006
Last updated: December 31, 2013
Last verified: December 2013
  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 Condition
Drug: HPPH
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Response [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2004
Study Completion Date: December 2013
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given IV
Experimental: Arm II
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00281736     History of Changes
Other Study ID Numbers: CDR0000441205, I 30404
Study First Received: January 24, 2006
Last Updated: December 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the esophagus
recurrent esophageal cancer
stage 0 esophageal cancer
stage I esophageal cancer
precancerous condition

Additional relevant MeSH terms:
Disease
Esophageal Neoplasms
Precancerous Conditions
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014