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Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

Primary Purpose

Non-melanomatous Skin Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HPPH
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, recurrent skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed non-morpheaform basal cell skin cancer Primary disease OR Recurrent disease after prior therapy (e.g., surgical excision, electrodesiccation, cryosurgery, or radiotherapy) At least 4 lesions, no greater than 2 cm in diameter and no greater than 5 mm in depth No lesions located on the eyelid, nose, ear, periauricular area, genitals, or digits, or any other lesions thought to be deep and/or aggressive PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 120,000/mm^3 Hepatic: PT/PTT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than 3.0 mg/dL Liver enzymes no greater than 2 times ULN No impaired hepatic function Renal: No impaired renal function Cardiovascular: No myocardial infarction within the past 6 months Other: No porphyria No known hypersensitivity to porphyrins No systemic lupus erythematosus No history of positive antinuclear antibody No history of degenerative disease of the retina No xeroderma pigmentosum No pancreatic disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 months since prior combination doxorubicin and radiotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy Surgery: See Disease Characteristics

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
March 3, 2011
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017485
Brief Title
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Determine the safety of HPPH used in photodynamic therapy in patients with basal cell skin cancer. Determine the drug dose, light dose, and treatment interval combinations that do not produce excessive toxicity to normal skin but effect tumor response in these patients treated with this regimen. Determine the length of time for cutaneous photosensitivity in these patients treated with this regimen. Determine the plasma clearance rates for HPPH in these patients. Determine the best combination of treatment parameters for a phase II study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanomatous Skin Cancer
Keywords
basal cell carcinoma of the skin, recurrent skin cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HPPH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-morpheaform basal cell skin cancer Primary disease OR Recurrent disease after prior therapy (e.g., surgical excision, electrodesiccation, cryosurgery, or radiotherapy) At least 4 lesions, no greater than 2 cm in diameter and no greater than 5 mm in depth No lesions located on the eyelid, nose, ear, periauricular area, genitals, or digits, or any other lesions thought to be deep and/or aggressive PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 120,000/mm^3 Hepatic: PT/PTT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than 3.0 mg/dL Liver enzymes no greater than 2 times ULN No impaired hepatic function Renal: No impaired renal function Cardiovascular: No myocardial infarction within the past 6 months Other: No porphyria No known hypersensitivity to porphyrins No systemic lupus erythematosus No history of positive antinuclear antibody No history of degenerative disease of the retina No xeroderma pigmentosum No pancreatic disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 months since prior combination doxorubicin and radiotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan R. Oseroff, MD, PhD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

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