Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer - Full Text View

Sponsor:	Roswell Park Cancer Institute
Information provided by:	Roswell Park Cancer Institute
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 Condition	Drug: HPPH	Phase II

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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

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
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

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:

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

No publications provided

Responsible Party:	Hector R. Nava, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT00281736 History of Changes
Other Study ID Numbers:	CDR0000441205, RPCI-I-30404
Study First Received:	January 24, 2006
Last Updated:	February 18, 2011
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:

Adenocarcinoma
Disease
Esophageal Diseases
Esophageal Neoplasms
Precancerous Conditions
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Neoplasms
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012