Phase I Trial of PC 4-PDT (NSC 676418) for Cutaneous Malignancies
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as assessed by physical exam and laboratory data.
weekly for 4 weeks and in week 6
Yes
Scot C. Remick, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU1Y97
NCT00023790
August 2001
February 2006
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |