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:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01238042
First received: November 1, 2010
Last updated: June 4, 2012
Last verified: June 2012
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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, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Barrett Esophagus Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013