Peter:
Results are as impressive as in MM trials. This should be results for end-stage brain cancer pts or who didn't have any other options. If true, results are very promising.
I wish that M. Gruber did elaborate bit more on his brain cancer results. Was this compassionate thalidomide usage, or full scale clinical trials with control arm ( I guess not, but do not know for real)? Also, he did probably combined thalidomide with standard chemo agents (for instance BCNU, procarbazine, cisplatin, carboplatin, 5FU,..).
Actually, I am looking forward to hear about prostate PII trials (conduced by NCI) after they expanded trials with now more than 50 pts. This is very broad end-point clinical trial. If there was no responded pts in first group trial would be terminated. So, results from this trial should also be good, but I will prefer o hear about before make any conclusion.
Also, one *oncologist* posted in yahoo message board (#2526) that combination of he inerferon-alfa and T in renal cells carcinomas had good results in NCI PII study. I was not able to locate this trial.
BTW, did you know that T is in pivotal study for primary Sjogren's Syndrome?
Miljenko
PS: Objectives in prostate PII trials (V. and VI., if positive, will be second evidence for T anti-angio mechanisms in humans):
OBJECTIVES:
I. Assess the clinical activity of thalidomide in hormone-refractory
adenocarcinoma of the prostate.
II. Evaluate two different dosing regimens of thalidomide for clinical activity.
III. Characterize thalidomide pharmacokinetics and determine if any
correlations exist between plasma concentrations and clinical activity or,toxicity.
IV. Evaluate the toxic effects of thalidomide treatment.
V. Determine whether urinary or serum levels of basic fibroblast growth factor, tumor necrosis factor, vascular endothelial growth factor, and tumor growth factor B are elevated in responding patients, and assess the effects of thalidomide on the circulating levels of these compounds.
VI. Correlate the degree of angiogenesis (or other pathologic markers) with response.
VII. Attempt to detect early signs of peripheral neuropathy, define the clinical/electrophysiologic parameters of the neuropathy, and correlate these parameters with other parameters such as plasma drug levels. |
