Clinical trial · Interventional
Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma
Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures
NCT01800838CI-TRIAL-00038672completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mycosis Fungoides/Sezary Syndrome | — | UNRESOLVED | — |
| Stage IA Mycosis Fungoides/Sezary Syndrome | — | UNRESOLVED | — |
| Stage IB Mycosis Fungoides/Sezary Syndrome | — | UNRESOLVED | — |
| Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage IIA Mycosis Fungoides/Sezary Syndrome | — | UNRESOLVED | — |
| Stage II Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
| silicon phthalocyanine 4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (silicon phthalocyanine 4 and PDT)
- description
- Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
- interventionNames
- Drug: silicon phthalocyanine 4
- Drug: photodynamic therapy
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- MTD of Photodynamic Therapy
- timeFrame
- Up to 30 days
- description
- 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.
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.