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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Barrett's Esophagus, CIS, HGD

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Optimal Light Dose

Outcome Description:

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

Outcome Time Frame:

24 hours

Safety Issue:

Yes

Principal Investigator

Hector Nava, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

RP 02-18

NCT ID:

NCT01238042

Start Date:

March 2003

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263