Adjuvant Interleukin2 (Proleukin)and 5-(3,3 Dimethyl-1-Triazeno) Imidazole-4-Carboxamide (DTIC) in Resected High-Risk Primary and Regionally Metastatic Melanoma
The prognosis of patients with malignant melanomas that are greater than 4 mm deep or
involve regional lymph nodes is poor, even after successful surgical removal. The concept
of adjuvant therapy for melanoma is derived from the hypothesis that these therapies may
kill micro-metastatic seeds of melanoma cells.
The rationale for this particular drug combination regimen is that melanoma cells may act as
a vaccine from which to generate melanoma-specific T cell expansion by way of IL2
administration. In unpublished results, forty-two stage II and III melanoma patients were
treated with this regimen at the University of Alabama with IRB approval. Analysis of
relapse free survival and overall survival in patients treated with this combination
suggested a small improvement in disease-free survival when compared to historical controls
or another study whose patients had similar but not identical staging (median follow-up time
of 30 months). Importantly, no unanticipated side effects were observed as a result of the
combination of these two drugs (both of which are FDA-approved for use in melanoma
patients).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse-free survival
The study duration is projected to be approximately 4 years.
No
Jason A Chesney, MD
Principal Investigator
James Graham Brown Cancer Center, University of Louisville
United States: Institutional Review Board
07.0008
NCT00553618
August 2007
August 2020
Name | Location |
---|---|
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |