Back from Chicago after meeting Dr. Jeffrey Raizer and hearing about some options in entering for my entry into a new clinical trial.
Option #1: A Phase2 Clinical Tria of Azixa (MPC827). This is a new, small molecule drug being developed by Myriad Pharmaceuticals. For this Phase-2 trial, total enrollment will be 68 patients with 10 at Northwestern in Chicago. Azixa’s is thought to be a microtubule destabilizing agent, causing arrest of cell division and programmed cell death, or apoptosis, in cancer cells. Azixa easily crosses the blood-brain barrier and is resistant to multi-drug resistance activity of certain tumor cells. These two features make it attractive. IV infusion Treatment is at Northwestern clinical research facility on day 1,8, and 15 of each 4 week “cycle”. Also, anbrain MRI will be taken every 4-8 weeks. Since Azixa has the potential for cardio toxicity (rare), ECGs are taken before and after each infusion along with measurement of blood troponin. Each visit to the clinic can take up to 6 hours due to the additional tests required along with the infusion.
Option #2: A Phase1/2 Clinical Trial of Cloretazine(Vion Pharma # VNP40101M) with Temodar. It’s mechanism causes it to interact with the cancer cell DNA and kill the cancer cell. Here is the typical cycle: 7 days on Temodar and then IV Cloretazine 2 hours after the last (7th dose) of Temodar over 15-30 minute infusion period. There is adequeate data suggesting that Cloretazine crosses the blood-brain barrier. If the tumor is held in check or is decreasing, than another cycle is warented. Meaning another 7 days of Temodar followed another IV dose of Cloretazine. A “cycle” lasts a total of 7 weeks. So treatments are 1 eek for each 7 weeks. An MRI is administered after the 7 week cycle yo note the effects on the tumor.
Option #3: A Phase 2 Clinical trial at Northwestern Uniyersity Medical center in Chicago. This one will use the drug Bortezomib (Velcade) prior to additional de-bulking surgery (at Northwestern) followed by more Vlcade with Temodar (Temodar). Velcade is part of a new class of drugs that act on a cellular control protein called NF-Kappa-B. These cycles are 28 days The major advantage of this option is that Velcade is already an approved drug for another type of cancer: Multiple Myeloma. But there are questions about its ability to cross the blood-brain barrier. The major disadvantage is that it requires more surgery including another craniotomy. Right now, we will let Dr. Raizer study my latest MRI scan and then have him consult with Dr. Nicholas on what they can agreepm on for my best option. Then of course, it’s up to Patty and me to make the final decision.
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Dear Phil
ReplyDeleteThaks for sharing and I wish you the best of luck. For your information I have pasted the info on the phase1 trials of Azixa below. Took from Myriad Pharmas homepage that contains more information should you be interested.
The toxicity mentioned above was not registered in any of the patients at the used dosage. I have below pasted the communication about the phase1 trials of Azixa communicated by Myriad Pharma.
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AZIXA™ Phase 1 Study Results Summary
Azixa has completed two Phase 1 clinical trials in a total of 66 patients, one in patients with refractory solid tumors that may also have had brain metastases and the other in patients with known brain metastases. The trials were designed to explore the safety and pharmacokinetics of Azixa and to find the maximum tolerated dose of the compound. In the Phase 1 studies, Azixa appeared to have a biological effect on patients´ metastases from many different primary tumors, including non-small-cell lung cancer, which is consistent with the mechanism of the drug candidate. Patients in the studies had typically failed from five to seven previous chemotherapy drugs and were determined by their physicians to be in the terminal stage of the disease, without further approved therapeutic options remaining. Of the 32 patients that received a therapeutic dose of Azixa, 38% responded as determined by tumor shrinkage, stable disease or disruption of the vasculature of the tumor. Two patients with brain metastases were still alive and stable after 15 months of treatment with Azixa.
During the Phase 1 trials, no apparent effect on any laboratory parameter was observed, including no reduction in neutrophils, platelets or hemoglobin. Importantly, there was no evidence of neurotoxicity, peripheral neuropathy or effect on QTc interval. There were a total of 55 serious adverse events in 34 patients in the two studies, however only 4 of these events in 3 different patients were classified as possibly or definitely drug-related. The dose-limiting toxicity was acute coronary syndrome, which was observed in none of the patients at 3.3 mg/m2, one of six patients at 3.9 mg/m2, and in two of six patients at 4.5 mg/m2. The maximum tolerated dose was set at 3.3 mg/m2. There was a transient increase in blood pressure during infusion and for several hours post-infusion.
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Look forward to your updates and hope for the best.
Greetings from Sweden!
Brgds
Robbie
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