Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00023790
Study type	Interventional
Source	Case Comprehensive Cancer Center
Contact
Status	Terminated
Phase	Phase 1
Start date	August 2001
Completion date	February 2006

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms