Well today Im at the cross roads again.
I dont know what path way is marked for me.
I knew my Mesothelioma had regrowth so Im prepared for a scan and the a bi-op and then a new drug but what I wasn’t prepared for was a phone call at 4pm with my Marsden Doctor asking me how Iam.
He told me they have decided not to wait for the scan result they have taken me off the MK3475-28 rechallange and he would send over by email the new trial.
I have received that and ray printed it off for me while I cooked dinner.
So we have a new plan now.
It made me laugh as I was wondering if I could blog but its written in the print off to talk to my friends. I think they realise just how many friends I have. So here you are world and all my friends.
Im going on the Hyper Phase 1 trial.
Hyper trial guadecitabine dose escalation With Pembrolizumab Mk3475 https://www.centerwatch.com/clinical-trials/listings/214463/castration-resistant-prostatic-cancer-combination-study-guadecitabine-pembrolizumab/?&radius=50
Brief description of study
HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110) a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.
Detailed Study Description
This is a phase I trial of the combination of the hypo-methylating agent guadecitabine and an anti-PD1 antibody (anti- programmed cell death protein 1) pembrolizumab. Patients will receive subcutaneous guadecitabine daily on Days 1-4 of each 21-day cycle. Patients will receive pembrolizumab intravenously once per 21-day cycle: on Day 8 of Cycle 2 and on Day 1 of each cycle from Cycle 3 onwards.
The rational for this design is that this pre-loading with Guadecitabine will sensitise the tumour to Pembrolizumab through the re-expression of genes that enhance tumour recognition, the increase in density of tumour infiltrating T-cells and stimulation of the adaptive immune response.
In Part A (Dose Escalation) the investigators will investigate escalating doses of Guadecitabine in combination with Pembrolizumab. Patients with advanced solid tumours will be recruited in cohorts of 3 to 6 patients to investigate the combination of 200 mg of pembrolizumab, administered as an intravenous injection, with escalating doses of guadecitabine, administered via a subcutaneous injection, once a day for 4 days (Days 1-4). Guadecitabine dosing will start at 45mg/m2 but can be decreased to 30mg/m2 in the event of toxicities or increased to 60mg/m2 in the absence of toxicities. Once the maximum tolerated dose is reached (or under the advice from the Safety Review Committee) patients will be enrolled to the dose expansion phase (Part B).
Part B (Dose Expansion): 20 patients will be recruited to Part B to further explore the safety and activity of the combination of guadecitabine and pembrolizumab. This cohort will include, but not be limited to patients with: castration resistant prostate cancer (CRPC), non-small cell lung cancer (NSCLC) and possibly other solid tumours based on emerging anti-tumour activity data from Part A and any other relevant preclinical or clinical published data.
Approximately 30 to 35 patients will be entered into this trial, 6 to 12 patients in Part A and 20 patients in Part B.
The anticipated accrual rate of the dose escalation phase will involve approximately 3 patients per month across 2 centres. Accrual rates could be higher or lower but this estimate takes into consideration that the first patient on an escalation cohort should complete Cycle 2 Day 15 prior to accrual of further patients in the cohort. Accrual in the expansion phase is estimated at 2-4 patients per month across 2 centres. It is expected that the duration of recruitment will be 12-24 months.
Clinical Study Identifier: NCT02998567
The side effects are simile to Chemo except one glaring thing that stands out to me ALOPCIA So I could lose my hair. Well I already knew that and I have 2 wigs so I will begin to use them so that I get used to wearing them.
So that is it I have to wait for the email with dates and try and work my speeches and conferences around them.
I just know Im going to get muddled with what is on what day. Take one day at a time
I have a inflated ball at the moment I dont know whether I dare to hope everything is going to be Ok as Im just not thinking at the moment. I cant get my brain around all this as I thought I would always be in remission.