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

NCT00281736 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000441205I 30404
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Precancerous Condition

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Efficacy

  3 years

Secondary Outcomes (2)

• Toxicity

  3 years

• Response

  3 years

Study Arms (2)

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

Arm II

EXPERIMENTAL

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

Drug: HPPH

Interventions

HPPH DRUG

Given IV

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Precancerous Conditions; Adenocarcinoma Of Esophagus

Interventions

2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hector R. Nava, MD, FACS

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: February 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: December 1, 2013
• Last Updated: January 3, 2014

Record last verified: 2013-12

Locations

US (1)