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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Precancerous Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Hector R. Nava, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000441205

NCT ID:

NCT00281736

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Precancerous Condition
  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • stage 0 esophageal cancer
  • stage I esophageal cancer
  • precancerous condition
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Precancerous Conditions

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263