The current randomized, multicenter, Phase III trial was conducted to determine whether the disease free interval and overall survival of patients with T2–T4,N0–N3,M0 squamous cell carcinoma (SCC) of the oral cavity or oropharynx could be extended through the combination of surgery (and radiotherapy, if required) with perilymphatic recombinant IL-2 (rIL-2).
Patients with a resectable T2–T4,N0–N3,M0 SCC of the oral cavity and oropharynx were assigned randomly to receive surgery and radiotherapy or to receive IL-2, surgery, and radiotherapy. Five thousand units of rIL-2 were injected around the ipsilateral cervical lymph node chain daily for 10 days before surgery. After surgery, contralateral 5-day rIL-2 courses were administered monthly for 1 year. The differences in disease free and overall survival between the two groups of patients were evaluated statistically.
Two hundred two patients finished the study. No significant complications related to rIL-2 were encountered, and surgery and radiotherapy were not hampered by its prior administration. Multivariate analysis conducted to determine the extent to which survival was influenced by rIL-2 and the other variables showed that rIL-2 significantly lengthened disease free survival (P
Is this the study you are referring to? ClinicalTrials dot gov Identifier: NCT00002702
Unfortunately, the recruitment status of the study is unknown because the information has not been verified recently. It seems like the trial was done in Europe.
I am very bullish on this stock but where are you getting this information. When I google the information you provide, it shows in an article dated July 1st, 2002. So, I'm just trying to get an idea of where you are going with this as it relates to Cel-Sci.
it was from 2002, google...Improved survival with perilymphatic interleukin 2 in patients with resectable squamous cell carcinoma of the oral cavity and oropharynx ......look for the header PDF(344K)-Wiley Online Library....The survival analysis of the entire randomized population, including protocol violators (intent to treat), is reported on the top in Figure 3, and analysis of the evaluable patients is reported on the bottom in Figure 3. Three years after randomization, 72 of 101 patients were still alive in the control group, and 79 of 100 patients were still alive in the rIL-2 group: The corresponding numbers of patients who survived disease free were 60 of 101 patients and 73 of 100 patients, respectively. The situation after 5 years was: the global survival rate was 55% in the control group and 73% in the rIL-2 group, and the corresponding disease free survival rates were 51% and 64%.......the other variables showed that rIL-2 significantly lengthened disease free survival (P