Status:
COMPLETED
Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
Kevin Cooper MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. Photodynami...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01800838
Start Date
April 1 2013
End Date
May 1 2015
Last Update
May 16 2019
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106