Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus

NCT01238042 | Completed Phase 1 DMC

• 1 other identifier: RP 02-18
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's Esophagus are injected with HPPH and one day later are endoscopically treated with light from a laser.

Conditions

Barrett's Esophagus; CIS; HGD

Outcome Measures

Primary Outcomes (1)

• Optimal Light Dose

  Using toxicity to normal surrounding tissue as a determinant and using two HPPH doses of PDT in HGD, CIS or early adenocarcinoma in Barrett's esophagus, to determine the optimal light dose at each HPPH dose

  24 hours

Secondary Outcomes (5)

• Toxicity to normal surrounding tissue

  24 hours

• Comparing HPPH to Photofrin

  5 years

• Effect of injection

  24 hours

• Efficacy of Treatment

  5 years

• Resolve Barrett's mucosa

  5 years

Study Arms (1)

Light Dose Escalation

EXPERIMENTAL

Light Dose escalated from 150 joules/cm to 200 joules/cm

Drug: HPPH

Interventions

HPPH DRUG

3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm

Light Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Patient must have biopsy proven high-grade (severe)dysplasia, carcinoma-in-situ or early stage adenocarcinoma
• Patient may have received prior therapy; e.g.Nd-YAG laser, radiation therapy or chemotherapy. At least one-month must have elapsed between prior treatments and PDT
• Tumors (HGD/CIS or early adenocarcinoma) can be primary or recurrent, Stage 0 or I N0M (any)
• Patients must have no contraindication to endoscopy
• Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A Pregnancy test is required and must be negative.
• Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB
• Patients must have a Karnofsky status 50 or above.
• Patients with early invasive adenocarcinoma will be included only if they are considered poor surgical risks, have failed or refused XRT/chemo, or refused surgery.
• If the patients has had cancer other than non-melanoma skin cancer, their treating physician must deem them disease-free.

You may not qualify if:

• Patients with tumors of grade greater than T-1.
• Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
• WBC\<4000; platelet count\<100,000; prothrombin times 1.5 times above upper normal limit.
• Patients with impaired renal and/or hepatic function (total serum bilirubin \> 3.0 mg/d, serum creatinine\>3 mg%, alkaline phosphatase (hepatic) or SGOT\> 3 times the upper normal limit.
• Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

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

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hector Nava, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 10, 2010
• Study Start: March 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)