We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01238042
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus CIS HGD Drug: HPPH Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2003
Primary Completion Date : October 2004
Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Light Dose Escalation
Light Dose escalated from 150 joules/cm to 200 joules/cm
Drug: HPPH
3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm

Primary Outcome Measures :
  1. Optimal Light Dose [ Time Frame: 24 hours ]
    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

Secondary Outcome Measures :
  1. Toxicity to normal surrounding tissue [ Time Frame: 24 hours ]
    To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH

  2. Comparing HPPH to Photofrin [ Time Frame: 5 years ]
    To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin

  3. Effect of injection [ Time Frame: 24 hours ]
    To determine the effect of a 24 hours interval between injection of HPPH and light treatment

  4. Efficacy of Treatment [ Time Frame: 5 years ]
    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. Resolve Barrett's mucosa [ Time Frame: 5 years ]
    An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238042

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Hector Nava, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01238042     History of Changes
Other Study ID Numbers: RP 02-18
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases