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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01238042
First received: November 1, 2010
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Barrett's Esophagus
CIS
HGD
Drug: HPPH
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Optimal Light Dose [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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:
  • Toxicity to normal surrounding tissue [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    To determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH

  • Comparing HPPH to Photofrin [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin

  • Effect of injection [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    To determine the effect of a 24 hours interval between injection of HPPH and light treatment

  • Efficacy of Treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Resolve Barrett's mucosa [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    An Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa


Enrollment: 18
Study Start Date: March 2003
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238042

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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01238042     History of Changes
Other Study ID Numbers: RP 02-18
Study First Received: November 1, 2010
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014