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Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

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ClinicalTrials.gov Identifier: NCT00017485
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

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.


Condition or disease Intervention/treatment Phase
Non-melanomatous Skin Cancer Drug: HPPH Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2000
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

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





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alan Oseroff, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00017485     History of Changes
Other Study ID Numbers: CDR0000068696
P30CA016056 ( U.S. NIH Grant/Contract )
RPCI-DS-95-34
NCI-G01-1953
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011

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

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