High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
The investigators have observed that many patients who had received high dose Interleukin-2
(IL2) and failed to respond to it but who then go immediately to temozolomide seemed to enjoy
extremely good responses which seem better quality and longer duration than typically
observed for temozolomide alone. To date, the investigators have observed 5 sequentially
treated patients with metastatic melanoma who had failed high dose IL-2 but who then went on
to receive immediate temozolomide. Two of these patients had complete responses and 3 had
very strong partial response. In a recent phase II study of extended low dose temozolomide
alone given in the same manner as the post IL-2 patients noted above, the response rate was
12.5% and all of these were partial responses only. The responses that the investigators
observed were at a much higher rate of response as well as much better quality than expected
for temozolomide. The responses were also better than those observed when temozolomide was
given first and then followed by high dose IL-2. The investigators concluded that perhaps the
major benefit the investigators observed was a result of the prior high dose IL-2 therapy
modulated by the temozolomide and that the sequence of treatment was clearly crucial for this
response.