Clinical trial NCT01238042: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Barrett's Esophagus
CIS
HGD
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Optimal Light Dose
timeFrame: 24 hours
Secondary outcomes:
measure: Toxicity to normal surrounding tissue
timeFrame: 24 hours
measure: Comparing HPPH to Photofrin
timeFrame: 5 years
measure: Effect of injection
timeFrame: 24 hours
measure: Efficacy of Treatment
timeFrame: 5 years
measure: Resolve Barrett's mucosa
timeFrame: 5 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Hector Nava, MD
role: PRINCIPAL_INVESTIGATOR
References: