The Seven-Per-Cent Solution?

I met with Dr. Luznik today to sign consents for a multi-institutional Phase II clinical trial, NA_00017193, that I’m participating in at Johns Hopkins. Two other top institutions, M.D. Anderson Cancer Center in Houston and Fred Hutchinson Cancer Research Center in Seattle, are also doing the same trial. I’ll spare you the full paragraph title and instead try to explain the procedure.

By the way, the pre-transplant chemotherapy is called the “conditioning regimen.” I’m having what’s called full myeloablative conditioning in which the bone marrow stem cells are destroyed or ablated. Older patients who would not be able to tolerate the high chemo doses are sometimes given a “mini transplant” instead. Full myeloablation was recommended for me based on my youthful age (smile), my general good health, and the severity of my MDS.

The term “standard of care” means the currently approved, normally used treatment as opposed to a “clinical trial.” For an extensive FAQ about clinical trials, go to this clinicaltrials.gov link. I loved what Dr. Luznik said to me about clinical trials: “We can’t do anything too crazy or no one would give us funding.” My conditioning regimen is standard of care and my post transplant regimen is a clinical trial.

First, the “standard of care” conditioning regimen part:

On Tuesday, November 23, I’ll be given a small test dose of the chemo drug Busulfan and get my blood drawn 10 times throughout the day to measure the concentration in my blood. Because each person will react somewhat differently to the drug, this is done to determine the proper dosage and also to test how my body will react.

Beginning on Wednesday, I’ll be given a full dose of Busulfan and another chemo drug called Fludarabine for four consecutive days. The Busulfan takes 3 hours to adminiser and the Fludarabine 1 hour. This therapy is often referred to as Bu/Flu (pronounced Boo-Flu) and is the standard procedure. I’ll also take Dilantin to prevent seizures that could be caused by the Busulfan, as well as anti-nausea medications as needed.

I’ll have a rest on Sunday, November 28, and have my transplant Monday night or the wee hours of the morning on Tuesday, November 30. The bone marrow taken from my donor will be given to me like a transfusion within 24 hours after harvesting from the donor.

Now begins the “clinical trial” part:

After a transplant, patients are normally given an immunosuppressant called Cyclosporin or a combination of two called Tacrolimus and Methotrexate for up to 6 months (or more) to try to reduce the risk of Graft vs. Host disease (GVHD). However, there is evidence from other studies that a two-day post-transplant administration of a drug called Cyclophosphamide (brand name Cytoxan) alone may be as good as the long term use of the other drugs.

Therefore, on days 3 and 4 after the transplant, I’ll receive Cytoxan along with another drug called Mesna to protect my bladder. This takes 1-2 hours each day via IV.

If this doesn’t prevent severe GVHD, a second drug called Mycophenolic Acid Mofetil (MMF) will be given to me orally for about 30 days. If this combination is still not enough, a third drug called Tacrolimus will be given orally for at least 45 days. Both MMF and Tacrolimus are currently licensed to prevent rejection of other transplanted organs but not to prevent GVHD. However, they have been used in many other studies to prevent GVHD.

Michael and I will try to post daily updates here about how I’m reacting to each phase. This is for our own documentation as much as for you. It’s easiest to keep all the info online in a central location. The nice thing about the blog is that we can selectively create private posts that only we can see if there are more personal details than we care to broadcast. Let us know if you have any questions. They might be good ones that we never thought to ask or answer.

Bonus section:

Finally, a reward for those of you who stuck with me through the bitter end of this post: “The Seven-Per-Cent Solution” is the name of a 1976 film in which Dr. Watson tricks Sherlock Holmes into going to Sigmund Freud for treatment of his cocaine addiction. It’s an excellent film, starring Robert Duvall as Dr. Watson, Alan Arkin as Sigmund Freud, Nicol Williamson as Sherlock Holmes, and Laurence Olivier as Professor Moriarity…well worth seeing if you can find it!

8 Comments:

  1. Wow! You will be getting a lot of drugs pumped into you. I guess they know how one will react with the other. It is scary. I don’t even like taking aspirin. I will look forward to the daily updates. We will keep you in our prayers. You are one tough mouse. Love you.
    Cathy 🙂

  2. Cathy – 🙁 Unfortunately, the drugs are heavy duty poison (the reason they’re administered hospital inpatient) but they are what’s necessary to kill the cancer and the old marrow to make way for the new, to keep the new marrow from being rejected, and to keep the new immune system from getting confused and attacking my healthy cells instead of the diseased ones. At least I don’t get radiation! Love, Karen

  3. Hey Karen,

    Sounds like a pretty intense treatment regime. I am so amazed at your positive attitude. I know it’s been a tough go of it for both of you. Don’t feel like I’ve offered much support to either of you, but please know you’re always in my thoughts. Take care and still want to try to get together. Hope you, Mike and the kitties are doing well. Your friend, Norma

  4. GOOD LUCK!!!!! Thinking of you!

  5. Thinking of you every day and will be following this closely.
    Love,
    Sarah

  6. Hi Karen – I am sending my best to you!! As I have learned thru your writings, you are a strong woman and can do this – best to you and your family.

  7. What an education we are all getting. Love you much, little sister/cousin. Linda

  8. ooh I hadn’t realised you were getting Busulfan and Fludarabine – I had those two for my transplant and they may has well been saline drips – no effect no effect on me whatsoever! Fingers crossed you’ll be the same, though admittedly I had a smaller dose because of my mini transplant.

    Mini transplants are also given for hypo-MDS, essentially when there’s so little working marrow that they don’t have to do much to kill what’s left! For me it was utterly perfect, even though I’m young and healthy. As long as you get away without having TBI, you’ll be fine!

    melissa (squirrellypoo on marrowforums)

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