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

Barrett's Esophagus Clinical Trial

Official title:

A Pilot 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238042
• Other study ID #: RP 02-18
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2010
• Last updated: December 1, 2014
• Start date: March 2003
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett's Esophagus
• CIS
• HGD

Intervention

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

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Toxicity to normal surrounding tissue	To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH	24 hours	Yes
Secondary	Comparing HPPH to Photofrin	To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin	5 years	Yes
Secondary	Effect of injection	To determine the effect of a 24 hours interval between injection of HPPH and light treatment	24 hours	Yes
Secondary	Efficacy of Treatment	A secondary objective is to determine efficacy of treatment at each set of paraments, i.e. ability to completely resolve the CIS, HGD or early cancer.	5 years	No
Secondary	Resolve Barrett's mucosa	An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa	5 years	No