Quick Update

I leave for Houston today.  I am now at the end of my first 9 week cycle on this new drug treatment/clinical trial.  So that means we will finally do scans.  Looking forward to seeing the results.  If the way I've been feeling since this treatment began is any indication, then I'm expecting to see good things on the scans. 

I meet with Dr. Falchook on Thursday and we will go over the scans and future treatment.  I'll check back in after that with an update. 

Melanoma Drug Trials

This week the New York Times has run a series of articles in their health section dealing with melanoma and drug trials. This article focuses on the B-Raf inhibitor drug by Plexxicon - PLX4032. This is one of the two drug trials we had hoped to take part in.  We were unable to get a slot in this drug trial, the trial I'm on works in a very similar fashion to PLX4032.  My drug is produced by Glaxo Smith Cline and is mentioned later in the series as a drug they would like to test in tandem with the Plexxicon drug.

The articles can be found here:
    Day 1 - A Roller Coaster Chase for a Cure
    Day 2 - After Long Fight, Drug Gives Sudden Reprieve
    Day 3 - A Drug Trial Cycle: Recovery, Relapse, Reinvention

This is a well written series that describes the clinical trials process, its difficulties and challenges.  It also speaks to the struggles of the cancer patients.  Being in the thick of it right now, has made this very compelling reading from my point of view. 

At this point I'm very grateful to be able to take part in this study.  It has certainly made a positive difference in our life.  We are sure there are still hills to climb, but we're very happy to be where we are now. 

As always thanks to everyone for your continued support. 

Good News

It is nice to be able to report some encouraging news. We have had a great two weeks with minor and major miracles to help us along the way.

We had some insurance coverage hiccups a few days before my planned departure for Houston to start the treatment two weeks ago. Thanks to a lot of caring and helpful people we got that resolved quickly and favorably and were able to go to Houston knowing that we had full insurance coverage for this treatment.

I went down on Sunday night (1/24) and stayed in Houston through Thursday (1/28). I had blood tests,and EKGs and visits with the study doctor, Dr. Falchook, to make sure I met the eligibility requirements for the study. All that went well and on Wednesday of that week, I started taking the new medication.

As part of the clinical trial they monitored me for 10 hours following my first dose. This included hourly blood draws and almost hourly EKGs. After that I went back to my hotel. The next day Thursday I had to return for another blood draw 24 hours after my first dose, then I headed home. I continue to take the medication via oral pill twice a day.

At this point I wish I had X-ray vision to be able to see what is happening to the tumors within my body. Unfortunately I don't, but there has been a significant metric that is pointing in the right direction. Since this started in July I have been taking pain medications to deal with the pain in my pelvic area. The dosages have escalated from a few ibuprofen a day in July to needing two Oxycodones every 4 hours to help alleviate the pain. On the Saturday following my first dose I took my last Oxycodone. Thanks to Dennis and Rosie for taking our kids for the weekend, Allison and I had a nice night out and short but fun hike together. Something that I hadn't felt up to for a long time. At this point it was starting to look like things were headed in the right direction. Sunday I took some Tylenol for a headache. But since then I have not taken anything for pain. I have gone for an entire week without needing any pain medication. Being able to walk with no pain is such a great feeling again. This morning I hiked to the top of Flagstaff and skied down, thanks to Curtis who broke trail the entire way up. I was tired at the end but it's something I wouldn't have even contemplated two weeks ago.

We are indeed very grateful for minor and major miracles, and for the prayers and efforts of many that helped bring them to pass.

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.