Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.

Funding Source - FDA OOPD

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kevin Cooper MD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Silicon; Silicon phthalocyanine

Criteria

Inclusion Criteria:

• Diagnosed with early stage MF (CTCL stage IA-IIA)

• Has at least 2 evaluable plaques

• Has been off systemic therapies for at least 4 weeks

• Has been off topical therapies for at least 2 weeks

• Has been off phototherapies for at least 2 weeks

• All skin photo-types will be included

• Subjects must have the ability to understand and the willingness to sign a written informed consent form

• Women of child-bearing potential must agree to utilize a birth control which results in a failure rate of less that 1% per year during the study; accepted forms of birth control for this study include: injections such as Depo-Provera and Lunelle, implants such as Norplant, and intra-uterine devices

• Sexually active males must agree to use a medically acceptable form of birth control for the duration of the study and for at least 3 months after the last dose of the study medication; appropriate birth control methods are using a condom with a spermicide or surgical sterilization

Exclusion Criteria:

• Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)

• Any medical condition that could be aggravated or may cause extreme discomfort during the study period

• Lesions only on the face, scalp or other sites that would make biopsies not cosmetically acceptable

• Women of childbearing potential who are pregnant or attempting to become pregnant are excluded from this study

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to silicon phthalocyanine (Pc 4) or other agents used in this study

• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements