Our few days earlier this week in the Washington, D.C., area – which were centered on my scheduled testing and interview at the National Institutes of Health’s National Cancer Institute (NCI) – have been dizzying. And shaky, as we got to experience an earthquake during the process. It wasn’t a big deal, but it was interesting to go through and observe, including the mandatory building evacuations.

The Mark O. Hatfield Clinical Research Center at NIH, seen after our evacuation after the earthquake

The Mark O. Hatfield Clinical Research Center at NIH, seen after our evacuation after the earthquake

The actual physical tests and examinations performed this past Tuesday at NCI were routine – taking my blood (13 different vials, though), an EKG, chest X-ray, and a urine sample.

Linda and I also spent time with a social worker who explained how treatment at NCI worked: it’s free to the patients, as it is a federally funded research facility, and they will even take care of transportation costs for the patient (but not the spouse or children of the patient) from anywhere in the U.S., as often as necessary. There’s also a small lodging stipend ($50/day) for the patient’s hotel room if the patient is an outpatient.

One of the benefits, in terms of treatment and medical care, of not having to deal with the costs of such care (personally or via insurance companies) is that there’s no wait or delay in waiting for pre-certifications or considerations about the expense of tests that may or may not produce useful results.

That philosophy became evident on Tuesday afternoon (after the hubbub from the earthquake we experienced had settled down), when the new Fellow (a term for a doctor on a long term rotation) assigned to me suggested I could have surgery in the next couple of days to remove my largest tumor to use in harvesting lymphocytes (immune cells) which would later be used to fight my rapidly spreading and growing melanoma.

The mere suggestion that they wanted to operate on me indicated that my acceptance into the so-called TIL (tumor infiltrating lymphocytes) protocol was almost a given at that point. That was a huge relief.

As part of our meeting with our Fellow, we also met with the Attending doctor who has worked at the NCI immunotherapy clinic for the last decade. Fellows rotate out every year in July, while the Attending doctors rotate every month or so, incidentally. They gave me a physical examination, palpating me to see if they could feel any tumors (and they thought they could feel some around my lymphadenectomy site). They also confirmed that the rapidly growing mole that I had on my right thigh, located about 1.5 inches from the old melanoma mole, was a new melanoma, as I had surmised a couple of weeks ago.

One initial idea raised at this meeting had been that they might try a radical surgery to remove both the large 3cm+ tumor found on the scans last month, as well as any other lymph nodes, in the hopes this might eliminate the cancer from my system, but after the examination and the identification of the mole they agreed that survey was not the way my cancer could be dealt with as I likely had some “melanoma channels” throughout which the cancer had spread and continues to do so. No surprise there – I already knew that instinctively based on how aggressive my melanoma has been.

In order to help determine the best course of action, as well as provide data that was incomplete in my records, I was asked if I could come in the following day for a brain MRI and a CT scan of my abdominal and thigh regions. We had fortunately tacked an extra day and a half to our trip when we planned it, so I was able to stay at NCI all day yesterday (Wednesday) for those two scans, which were arranged for me by a uniformed research nurse who is our direct link with any information or support we need on the medical side.

At the end of the day I exchanged e-mail with our Fellow, and she informed me that the CT scan did confirm that all my tumors were continuing to grow (again, no surprise there), but that from a treatment perspective, this was helpful as it provided more potential samples, as well as reference tumors to use to see if the treatment was working once started. However, surgery was not happening this week, as she and the Attending wanted to present my case formally to their colleagues at the weekly Monday staff meeting, and solicit ideas on how to best proceed with my tumor resection and subsequent treatment.

The clinical protocol, which is really a clinical trial, discussed with everyone on Tuesday has several steps.

First is the harvesting of lymphocytes from a tumor. They need at least a 2cm wide tumor to do this, and my largest tumor is quite a bit larger than that at this point. This is an invasive procedure but in the case of my tumors in the lymph nodes is less tricky than removing a tumor from an organ which thankfully my melanoma hasn’t gone there yet.

Next, the labs at NCI extract the lymphocytes and grow them. They use Interleukin-2 (IL2) to help “boost” the cells as they breed them. This process takes a couple of weeks or so, if it is successful.

Once it is confirmed that the lymphocytes are replicating and growing properly, I would get flown down to NCI to be formally admitted into the clinical trial.

For those of you interested in the details, the link to this trial is here. There is also a really good FAQ here.

In case you also are interested, the rather scientific title of the trial is “Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI)”.

Once I signed the agreement to participate in the trial, a computer would flip a virtual coin to randomize me into one of the two arms of the trial. The first arm is the basic TIL treatment, while the second arm is the basic TIL treatment with total body irradiation (TBI), namely three days of extreme radiation treatment. As I understand it, the purpose of the trial is to determine whether or not the radiation component increases the cure rate appreciably or not across a wide range of people. The current belief is that it makes a small difference, but this trial will help quantify that difference. That in turn will help determine whether the amount of difference is significant enough to justify the abuse of the body the radiation treatment adds to the process.

If my virtual coin flip put me into the arm with TBI, I would stay as an inpatient for a week at NCI while they extracted stem cells from me. These stem cells would be grown and stored for reinjection after the radiation treatment was over, since the TBI would kill all the cells in my bone marrow, which include cells which generate all of my white blood cells (for fighting infection, among other things).

This initial visit would be shortly followed by another visit to actually perform the core part of the treatment.

First step in the treatment would be to have five days of chemotherapy to kill my immune system and create a vacuum to allow my boosted lymphocytes to both have a more dramatic effect on my melanoma tumors (as well as individual bits of melanoma floating in my system) as well as prevent my body from just reabsorbing the injected lymphocytes without letting them perform their intended function. Note that the chemotherapy would be unlikely to have any effect on the metastatic melanoma in my system.

The chemotherapy side effects would be much the same as for traditional cancer chemotherapy, including full body hair loss, nausea, fatigue, etc.

If I were in the TBI arm of the trial, the chemotherapy would be immediately followed by the full body radiation, which has a pretty nasty set of side effects, some of which overlap with those from the chemotherapy. The radiation side effects can (and likely will) last many months, or even the rest of my life (including infertility – fortunately not something I am concerned with at this point in my life). The radiation would further weaken my immune system in order to make my reintroduced lymphocytes more effective.

Once my immune system was wiped out, the lymphocytes would be administered via an IV, and if I were in the TBI arm, the harvested stem cells would be administered as well to help my bone marrow regenerate to rebuild my immune system.

I would then go on a short course of intensive IL-2 (up to 15 doses, given eight hours apart) to further boost the lymphocytes now in my body, to help them better battle my cancer cells. After that it would be just a matter of time to recover from the nearly two week abuse of my body in order to try and cure the cancer.

The amount of time for recovery from the highly weakened state depends greatly on a number of factors, but the trial documents suggest for the non-TBI arm it should be two to three weeks in the hospital. For the TBI arm, it would be that plus four to six months of recovery to overcome the recurring fatigue, nausea, and other side effects that will undoubtedly arise.

There would also be return visits back to NCI every four to six weeks for scans to see how effective the treatment was. That would go on for a year, with semi-annual visits after that.

The one thing that this arduous treatment offers that so far we had not heard is the possibility of a near total cure. Statistically this has occurred in approximately 50% of the subjects, but that’s a heck of a lot better than the odds with traditional adjuvant treatment for melanoma, which in most cases, if it works, only seems to put off a subsequent recurrence to a later date (albeit potentially a much later date). And that difference – between a cure and a delay – is what will make this TIL treatment – with or without TIB – worth all the sacrifices necessary to get through the treatment.

In closing, I would like to also give special thanks to my new friend Jamie. Jamie blogs as Melanoma Mom (http://melanomamom.blogspot.com) and has been getting treatment at NCI since March for metastatic melanoma (read her blog for details). She and her husband Jeff are incredibly well-informed about various trials and protocols at NCI, as well as the logistical issues of being an in-patient at NCI. And Jamie is taking part in a rather revolutionary treatment herself starting in about two weeks at NCI. She, Jeff, and their beautiful baby boy, Kai, were kind enough to get together with us on Tuesday night (they live only 20 minutes from NCI). We learned so much from her and Jeff, and are thankful to number them among our friends now.

One simple thing Jamie taught us that I can easily share with you is a toast when you share a drink with others: “To NED!”

NED is an acronym for “No Evidence of Disease”, and that’s Jamie’s goal and my goal for our respective melanomas.

So please hoist your glasses to NED, often and with gusto! I know I certainly will!

My next post will be once my treatment course and schedule solidify just a bit, hopefully early next week.