I am now on Week 3 without any treatment. This was rather unsettling until I heard that the clinical trial needed a four-week-washout of no treatment. That settled me down a bit.
The last time I wrote, I mentioned my gestational diabetes history being a possible block to my participating in the trial. At first, the protocol director at the drug company said, "Absolutely NOT! She cannot participate." My oncologist went to bat for me and said, "This woman had gestational diabetes 12 years ago. Her blood sugars are of no concern and she should not be excluded based on something that was over a decade ago." Protocol director: "Okay. She's in."
Wow! Praise God!
But . . . still waiting. The definition of protocol is, "The established code of procedure or behavior in any group, organization, or situation." (dictionary.com) The very nature of "protocol" can be fraught with bureaucracy beyond belief. Because clinical trials are very closely monitored by the Food and Drug Administration (FDA), exact procedures must be followed in order for them to be accepted.
Without going into painful detail, I'll just say that the trial start was delayed last week til today and today, it was delayed again. The new target start date is August 16. My oncologist has emphasized how important this is to get the trial started by then because I will have completed the washout time period and she doesn't want those four weeks to go to waste.
If that's the case, I will go through the complete screening the week of the 19th and most likely start the treatment the week after.
However, if the trial does not open on the 16th, then I will start a different treatment (Letrozole) the week of the 19th. I will still need to repeat my scans as they'd like to know what has happened during this month off treatment. That will help them gauge the speed of the cancer.
When I came from Hong Kong, I brought my tissue samples with me for repeat pathology studies. I received a phone call today telling me that the pathology lab returned those samples to Hong Kong! There are no blocks or slides with samples of my cancerous tumor. This means that they are going to have to try to get a biopsy from one of my bones. This can be somewhat difficult to do and a new member will be added to my medical team: a neuroradiologist. If the neuroradiologist doesn't think it's feasible to get an adequate bone sample without too much risk, then they will try to enter me into the study as a "wildcard." Don't ask. I really can't explain it!
So there we are. Still waiting.
In summary:
Prayer points:
The last time I wrote, I mentioned my gestational diabetes history being a possible block to my participating in the trial. At first, the protocol director at the drug company said, "Absolutely NOT! She cannot participate." My oncologist went to bat for me and said, "This woman had gestational diabetes 12 years ago. Her blood sugars are of no concern and she should not be excluded based on something that was over a decade ago." Protocol director: "Okay. She's in."
Wow! Praise God!
But . . . still waiting. The definition of protocol is, "The established code of procedure or behavior in any group, organization, or situation." (dictionary.com) The very nature of "protocol" can be fraught with bureaucracy beyond belief. Because clinical trials are very closely monitored by the Food and Drug Administration (FDA), exact procedures must be followed in order for them to be accepted.
Without going into painful detail, I'll just say that the trial start was delayed last week til today and today, it was delayed again. The new target start date is August 16. My oncologist has emphasized how important this is to get the trial started by then because I will have completed the washout time period and she doesn't want those four weeks to go to waste.
If that's the case, I will go through the complete screening the week of the 19th and most likely start the treatment the week after.
However, if the trial does not open on the 16th, then I will start a different treatment (Letrozole) the week of the 19th. I will still need to repeat my scans as they'd like to know what has happened during this month off treatment. That will help them gauge the speed of the cancer.
When I came from Hong Kong, I brought my tissue samples with me for repeat pathology studies. I received a phone call today telling me that the pathology lab returned those samples to Hong Kong! There are no blocks or slides with samples of my cancerous tumor. This means that they are going to have to try to get a biopsy from one of my bones. This can be somewhat difficult to do and a new member will be added to my medical team: a neuroradiologist. If the neuroradiologist doesn't think it's feasible to get an adequate bone sample without too much risk, then they will try to enter me into the study as a "wildcard." Don't ask. I really can't explain it!
So there we are. Still waiting.
In summary:
- Plan A is for trial to open August 16 with complete screening the week of the 19th and for treatment to begin the week of the 26th. There is a possibility that I will have a bone biopsy (which can be painful) sometime before then.
- Plan B is to start a different treatment the week of the 19th should the trial not open on the 16th.
Prayer points:
- As always, we continue to ask for God's healing. I am still working on my thoughts on miracles and waiting on God, but let's just say that I am excited about my future, no matter how long or how short it may be here on this earth. God hasn't given up on me and I haven't given up on him. My faith in him is not based on whether or not my cancer is healed. My faith in him is based on the fact that he is God, my beloved Redeemer.
- I'd like to participate in this study (God willing). Please pray that things work out to do so.
- I have much praise that I am in little pain and that I am able to pretty much live a "normal" (whatever that means!) life.
- The kids are doing great and are currently at Middle School Church Camp. Art and I are having a much needed get-away on Friday and Saturday while they are gone.
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