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| Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017485 |
Purpose
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer.
| Condition | Intervention | Phase |
|
Non-Melanomatous Skin Cancer |
Drug: HPPH |
Phase I |
| MedlinePlus related topics: | Cancer Skin Cancer |
| ChemIDplus related topics: | 2-(1-Hexyloxyethyl)-2-devinyl pyropheophorbide-a |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study Of Photodynamic Therapy (PDT) For The Treatment Of Basal Cell Carcinoma (BCC): A Drug/Light Dose Finding Study Utilizing 2-(1-HEXYLOXYETHYL)-2-DEVINYL PYROPHEOPHORBIDE-A (HPPH-PHOTOCLOR) |
| Study Start Date: | January 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive HPPH IV on day 1. Patients undergo phototherapy on days 2-3.
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the minimum erythemal dose (MED). The MED is defined as the dose combination of HPPH and laser light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at which at least 2 patients experience grade 1 or worse toxicity.
Patients are followed daily for 4 days, at week 1, and at months 1, 3, 6, 12, and 24.
PROJECTED ACCRUAL: A total of 4-25 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-morpheaform basal cell skin cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, New York | |||||
| Roswell Park Cancer Institute | |||||
| Buffalo, New York, United States, 14263-0001 | |||||
| Roswell Park Cancer Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Allan R. Oseroff, MD, PhD | Roswell Park Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068696, RPCI-DS-95-34, NCI-G01-1953 |
| First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017485 |
| Health Authority: | United States: Federal Government |
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