Clinical trial · Interventional
Safety Study Using Photodynamic Therapy Light Therapy for Patients With Chest Wall Progression of Breast Cancer and Satellite Metastases of Melanoma
A Phase I Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) for Patients Failing Radiation Therapy
- 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 research is intended to explore a new approach to therapy when breast cancer recurs in the skin. The treatment, known as continuous low-irradiance photodynamic therapy, or CLIPT, has shown great promise in animal studies. The investigators goal is to evaluate CLIPT in people, using a novel light delivery system, to assess its side effects and the benefit it has in treating cancer. The investigators goal is to develop a safe, effective therapy that can be given in the doctor's office or possibly at home.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CLIPT patch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- description
- 100 J / cm2 over 24 hours
- interventionNames
- Device: CLIPT patch
- type
- EXPERIMENTAL
- label
- 2
- description
- 200 J / cm2 over 24 hours
- interventionNames
- Device: CLIPT patch
- type
- EXPERIMENTAL
- label
- 3
- description
- 400 J / cm2 over 24 hours
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years of age, with primary or metastatic cutaneous tumors that have been previously irradiated. * Patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver CLIPT (10 x 10 cm for Target lesion, and 1 x 1 cm for Control site). * Patients must have a target lesion in a location other than the hands, feet, genitals, or face. Lesions in those locations will be excluded. * Patients must sign informed consent. Exclusion Criteria: * Patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study. * Patients must not have received radiation therapy to the target site within 60 days of enrolling on this study. * Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded. * Pregnant and nursing patients will be excluded. Women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment. * Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) will be excluded. * Laboratory values (Note: these are provided by the potential patient): * Absolute neutrophil count \> 1000. * Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT \> five times upper limit of normal) will be excluded. * Adequate coagulation status as indicated by platelet count \> 50,000, PT and PTT \< 1.5 time the upper limit of normal. * Negative Urine or Serum Pregnancy Test Note: No cost to patient, and no compensation provided.
References
Publications (0)
Data not yet available