Clinical trial · Interventional
Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin
Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
- 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)
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| imiquimod | Drug | Imiquimod | ALIAS |
| immunologic technique | Other | — | UNRESOLVED |
| indocyanine green solution | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Toxicity and tolerability by CTCAE version 3.0
- measure
- Complete systemic and local response rates at 16 months
Secondary outcomes (1)
- measure
- Immunologic parameters
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma meeting the following criteria:
* Stage III or IV disease
* Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed
* Presence of 1 or more cutaneous metastases ≤ 3 cm in size
* Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness
* No uncontrolled brain metastases
* Treated brain metastases that are stable for 3 months allowed at the investigator's discretion
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 4 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study completion
* No known allergy to any drugs used during study treatment
* No unstable medical illness
* Not immunosuppressed
* Patients immunosuppressed due to disease (e.g., HIV positive) allowed
PRIOR CONCURRENT THERAPY:
* No systemic steroids or any other immunosuppressive medications within the past month
* No chemotherapy within the past 4 weeks
* No radiotherapy to the treatment site within the past 4 weeks
* Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed
* No concurrent immunosuppressive agentsReferences
Publications (2)
- BACKGROUNDLi X, Naylor MF, Le H, Nordquist RE, Teague TK, Howard CA, Murray C, Chen WR. Clinical effects of in situ photoimmunotherapy on late-stage melanoma patients: a preliminary study. Cancer Biol Ther. 2010 Dec 1;10(11):1081-7. doi: 10.4161/cbt.10.11.13434. Epub 2010 Dec 1. PMID 20890121
- BACKGROUNDNaylor MF, Chen WR, Teague TK, Perry LA, Nordquist RE. In situ photoimmunotherapy: a tumour-directed treatment for melanoma. Br J Dermatol. 2006 Dec;155(6):1287-92. doi: 10.1111/j.1365-2133.2006.07514.x. PMID 17107404