Phase 1
N=11
Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma · Recurrent Mycosis Fungoides/Sezary Syndrome · Stage I Cutaneous T-cell Non-Hodgkin Lymphoma · Stage IA Mycosis Fungoides/Sezary Syndrome · Stage IB Mycosis Fungoides/Sezary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01800838 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: MTD of Photodynamic Therapy — 150 J/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- silicon phthalocyanine 4 (Drug); photodynamic therapy (Drug); pharmacological study (Other); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kevin Cooper MD
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MTD of Photodynamic Therapy |
150 | — |
| PRIMARY MTD of Silicon Phthalocyanine 4 Defined as the Dose Immediately Below the Dose in Which 2 or More of 6 Patients Experience a Grade 4 Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
0.1 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01800838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.