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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HPPH

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2014
First posted
Nov 10, 2010
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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