Alain H Rook, MD, Professor of Dermatology at the University of Pennsylvania, Philadelphia, PA, USA, with funding from the National Cancer Institute, the Food and Drug Administration and the Leukemia and Lymphoma Society, conducted an investigator-initiated study with topical resiquimod gel, 0.03% and 0.06%, in early stage patients with cutaneous T-cell lymphoma, also known as mycosis fungoides.
The participating 12 patients had been on previous treatments to which they were no longer responding. The study showed that the treated skin lesions significantly improved in 92% of the patients while 30% had their skin lesions completely cleared. One patient had no progression of the disease. One patient experienced complete clearing of CTCL lesions for more than 3 years (investigator observation). It was also determined that resiquimod gel could induce resolution of distant skin lesions that were not treated with the gel which is unique as this has not been previously observed with any currently used topical therapies. Importantly, using a highly sensitive assay, it was determined that the malignant T-cells were completely eradicated or reduced among 9 of 10 patients studied.
The side effects were considered tolerable and manageable and limited to local irritation of the skin. In patients whose skin lesions cleared completely or almost completely, it was believed to be due to an expansion of the patient’s own defensive immunity comprised of killer T-cells in treated lesions that lead to an increase of the clearance of the malignant T-cells of the disease.
Therefore, treatment with resiquimod gel appeared to have the potential to induce an anti-tumor response both locally and at distant untreated lesions. Galderma Research and Development, LLC is conducting another clinical study to assess the effectiveness and safety of different resiquimod doses to treat the patch and plaque lesions present in this early stage of the disease.
For more details about the study, visit the NIH U.S. National Library of Medicine - ClinicalTrials.gov website (condition or disease: CTCL; other terms: Galderma).
Rook 2015 et al. Topical resiquimod can induce disease regression, eradicate malignant T cells and enhance T cell effect functions in cutaneous T-cell lymphoma. Blood. 2015;126 (12):1452-61)