Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is metastatic to the skin.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.
Head and Neck Cancer
Non-melanomatous Skin Cancer
Drug: silicon phthalocyanine 4
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies|
- Toxicity as assessed by physical exam and laboratory data. [ Time Frame: weekly for 4 weeks and in week 6 ] [ Designated as safety issue: Yes ]
- Disease response as measured by skin assessment and photography [ Time Frame: weekly for 4 weeks and in week 6 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2001|
|Study Completion Date:||February 2006|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Drug: silicon phthalocyanine 4
- Determine the maximum tolerated dose (MTD) of silicon phthalocyanine 4 (Pc 4) when administered with a fixed dose of light in patients with advanced cutaneous malignancies.
- Determine the MTD of the light when administered with a fixed dose of study drug in these patients.
- Determine the pharmacokinetics of Pc 4 in these patients.
- Determine the clinical antitumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive silicon phthalocyanine 4 (Pc 4) IV over 2 hours on day 1 followed by light therapy over 30-60 minutes on day 2. Treatment repeats in 6 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of Pc 4 and a fixed dose of light until the maximum tolerated dose (MTD) of Pc 4 is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for Pc 4 is determined, additional patients are treated with a fixed dose of Pc 4 (2 dose levels below the MTD) and escalating doses of light until the MTD is determined. The MTD of light is defined as above.
Patients are followed at 6 weeks (or 8 weeks if treated lesion on lower extremity has not healed) and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study annually.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023790
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|