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Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00017485
First received: June 6, 2001
Last updated: March 3, 2011
Last verified: March 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 6
Study Start Date: January 2000
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017485

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Allan R. Oseroff, MD, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alan Oseroff, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00017485     History of Changes
Other Study ID Numbers: CDR0000068696, P30CA016056, RPCI-DS-95-34, NCI-G01-1953
Study First Received: June 6, 2001
Last Updated: March 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
basal cell carcinoma of the skin
recurrent skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms by Site
Neoplasms
Skin Diseases
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on May 19, 2013