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Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00017485
Collaborator
National Cancer Institute (NCI) (NIH)
6
Enrollment
1
Location
84
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
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 :
Jan 1, 2000
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Jan 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00017485
    Other Study ID Numbers:
    • CDR0000068696
    • P30CA016056
    • RPCI-DS-95-34
    • NCI-G01-1953
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Mar 7, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    basal cell carcinoma of the skin
    recurrent skin cancer
    Additional relevant MeSH terms:
    Skin Neoplasms

    Study Results

    No Results Posted as of Mar 7, 2011