Wednesday, January 13, 2010

Phase 1 Trial

Well since I last updated on Christmas day, there has been a lot happening.  There have been a lot of balls up the air that made us hesitant to post an update only to have to change it days later.  However at this point, many of the balls have landed and we think we know where the others will end up. 

On December 28th I had new scans (restaging in cancer speak) to give us a view of the state of the tumors.  The results were not what we had all been hoping for.  The chemo treatment I had undergone had not been effective at reducing the size of the tumors.  It may have slowed it, controlled its growth, but it didn’t reduce the tumors in size.

Percent of growth in the interval between my last two scans is about 20%.  According to the cancer docs anything less than 20% is considered stable disease and they consider the treatment effective if they can maintain stable disease.  Based on these results and what was medically considered ‘stable’ disease, I was given the option to continue with the current chemo until the time that the TIL cells are ready for re-infusion (early March).  This wasn’t what Dr. Grossmann at HCI thought would be best, but it would be a valid approach if we wanted to.  We weren’t keen on continuing with the chemo, without positive results. 

At this same time, Dr. Grossmann had been in conversation with MDACC and two clinical trials for new drug treatments had a few slots open up at MDACC.  Both drugs are showing excellent results for melanoma patients with distal metastases (cancer spread to other parts of the body).  The only problem was we had to get to Houston to see the study lead investigators to be enrolled in the study and it was Wednesday afternoon with Friday and Saturday being New Years Eve and New Years Day.  So we had to wait until Monday to get an appointment at MDACC.  Turns out that one of the two trials (our first choice of the two in fact) had filled immediately, and no slots were available.  The second trial had slots available and the lead investigator for that trial at MDACC (Dr. Falchook) squeezed me into his schedule on Thursday.  So I headed to Houston with my Dad to meet with Dr. Falchook and to learn more about the study.

This study is for a new chemo drug that targets the BRAF pathway in a cancer cell.  Quick explanation is that if you take out the BRAF pathway then the cell nucleus doesn’t get the signal to reproduce.  Therefore the cells die without reproducing.   This ultimately leads to tumor reduction.  This drug is in a phase 1 trial, which means it is the first treatment on human patients.  And typically Dr. Grossmann doesn’t like to send his patients off chasing unproven phase 1 trials.   However in this case, this drug is very similar to another drug currently in phase 3 (final stage) clinical trial that has very promising results.  This phase 1 trial has been going on long enough that they have some preliminary data that shows this as being very effective as well.   With this initial data, it appears that somewhere between 60 and 80% of patients have seen tumor reduction on this treatment.  This is a chemo drug that I will take orally as a pill 2 to 3 times a day.  So far the side-effects have been very slight for the study participants. 

There are still some hoops I have to jump through before I get the medication.  On our trip to Houston last week I signed the consent form to take part in the study and this guarantees my slot will be held for me.  In order to get the medication I still need to take some tests – echo cardiogram, cardio stress test, and some labs drawn.  The assumption is that none of these will be a problem and I will meet the eligibility requirements for the study.  Once that is complete, I’ll meet with Dr. Falchook again and we’ll start the treatment.  As of right now, it appears that I’ll head to Houston and have the tests done on the 25th, meet with Dr. Falchook on the 26th and start the treatment on the 27th of this month. 

There will be some significant travel between here and Houston while on the study so they can monitor my health and progress during the treatment.  But we feel like this is the best option we’ve had so far and we need to take a shot at it.  I’m honestly excited to be able to take part of this study.  I feel very optimistic about the outcome and feel like we’ve been given a great opportunity to be able to have this drug made available for my treatment.

As is par for the course, we’ll do new scans 9 weeks into the treatment, if they show positive results we’ll keep going with this treatment.   If not, it is likely that we’ll look to TIL at that point.  But we’re hoping and praying that this works the way we need it to and the TIL ends up not being needed. 

We continue to receive lots and lots of well wishes and support from all over, and it is all much appreciated.  We hope the New Year is great for everyone and that 2010 turns out to be a great year to remember. 

12 comments:

Katy said...

We will be rooting for you with this new trial! Good luck and always know you're in our thoughts and prayers.

Love,
The Smith Family

Mark G said...

We're so happy to hear that there are more options out there. This is great news about the trial. Hang in there bro!
Mark and Ginger

Judy said...

Ben, this trial sounds promising. Will put your name on the temple prayer list today. Love you and your family.

Judy

RLRP said...

I feel uplifted by your post, thanks for sharing . I'm so happy that there have been some positive results with this new drug. We're continuing to really pull for you and think of you and your family daily.

ghd3 said...

Thank you Ben, for the update. This is great news about the trial. Keep us posted, and know that we continue to think about you daily. It was so great to see you guys in SLC over the holidays!

Go TEAM FIRESTORM!

Anonymous said...

Beat this thing. Please. I'm desperately rooting for you and your family! I'm way too familiar with this disease, and it owes me one...

Tammy Sellers
sellerstamara@hotmail.com

Sarah Schmidt said...

Hello Jacobsens!

This sounds like really good news. It's amazing the ways that are being found to beat cancer at its game. I am so glad you are in good hands. Love you all!

Sarah

Sarah said...

I am thinking about you this week! You continue to be in our prayers.

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James said...

Hey Ben,
I'm always hopeful reading your posts. Keep fighting this thing. I hope all goes well at MDACC. We'll have to catch up when you get back.
-James

Dave and Georgia said...

Ben,
We admire your positive attitude and are thinking and praying for you. You are learning about a whole new world of the most complex medicine, which we know you would just as soon not have to know about. Keep up the posts. Dave and Georgia

Whitney said...

Ben, Al and kids... thank you for the update. I am excited to hear how the trial goes... what an opportunity to be part of a new trial drug. It sounds very positive and will hopefully prove to be effective in ridding your body of this cancer. Somehow it "feels good".

I truely believe 2010 will be your year to heal and move forward. Please keep the posts coming when you are able.

Thinking of you always,
Whitney Evans