Finding studies
Finding studies
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Lead
Case Comprehensive Cancer Center
With
OBJECTIVES: * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
