MORE LEUKEMIA RESEARCH TO SMILE ABOUT

Well  Thanksgiving is over, but my gratitude is not. I am grateful for my family, my friends, my online CLL friends, and the amazing researchers and staff at the National Institutes of Health. How very blessed I am to have the opportunity of being in the NIH ibrutinib clinical trial. I am grateful to have my 15 minutes of fame on this earth by being a participant.

Dr. Mohammed Farooqui will be presenting some of his findings from our clinical trial at the American Society of Hematology in Atlanta, Georgia in December 8-11. One of his findings is that platelet function does not seem to be affected negatively for participants on the experimental drug ibrutinib.

His abstract can be found at this link:
https://ash.confex.com/ash/2012/webprogram/Paper50250.html

My friend Michael Novak also alerted me to a new finding in the leukemia world. Dr. Robert Weinkove is a Clinical Research Fellow at the Malaghan Institute of Medical Research in New Zealand. His research focuses on vaccinating leukemia patients through stimulating the activity of an immune cell called invariant natural killer T (iNKT). This is another targeted immune therapy.

Here is the link, if you would like to read the entire article:
http://www.malaghan.org.nz/news-and-events/boosting-immune-responses-against-leukaemia/
http://sciencealert.com.au/news-nz/20122011-23865-2.html

We are at the brink of discovery. The maintenance of leukemia for high-risk patients, and perhaps even the cure are right around the corner.

I am headed out to Bethesda, Maryland next week. I will be posting the results of my tests after I return.

HAPPY DANCE TIME AGAIN

Boy, did I have a wonderful trip to National Institutes of Health in spite of the scare that my flight could have been cancelled because of Hurricane Sandy. George and Matt (my PCI brothers), who began the clinical trial on the same day as me, both made it to NIH, and that made me very happy. I had dinner with my cousin Sammy, who works at NASA, had two non-stop flights, sat in the window seat each flight, read half of my book, slept on the plane on my way home, chatted and laughed with my wonderful OP7 (Outpatient Floor 7) friends, had my Chi Tea latte non-fat vente… Who could ask for anything more?

I delivered a copy of the letter I sent to President Obama about NIH and the request for continued funding to the NIH research staff. This is the way medical care should be done. I am forever grateful and I cannot say it enough.

One issue that needed to be addressed was the Hurricane Sandy and flight cancellation situation. We discussed this with the research nurse and found out that according to the drug company, Ibrutinib cannot be shipped to us, if a disaster happens again. It must be picked up in person. This is not very logical to me. If another disaster happens, it seems like we should be able to get local outpatient blood work that could be expedited and faxed to NIH. Then if our neutrophils are high enough, we should qualify for the next supply of the drug. NIH is talking with the drug company again about this. Sounds like the drug company needs a Plan B.

In a prior post I mentioned that as of October 4, 2012 the clinical trial at National Institutes of Health in Bethesda, Maryland (NCT01500733) has been suspended and is currently under review. I emailed those who asked what this implies. I will repeat it again. What this means is that existing participants are not affected. New participants waiting to start the drug may have a little delay. This is normal procedure in reviewing a clinical trial at NIH.

THE GOOD NEWS!

My white blood cell count has continued to go down from 84,500 to 68,170 (another 16,330). I am now beginning Cycle 5 of Ibrutinib. Everything is headed in the right direction. Everyone I have talked to at the trial is responding well or at least maintaining. We are the happy people sitting in the OP7 lobby.

SIDE EFFECTS FOR CYCLE 4

These are my side effects for Cycle 4, which may or may not have been caused by the drug:

• At the beginning of Cycle 4 (October 7) I returned home from a grueling 7½ hour flight from Baltimore. My left side, my left waist and my left back were so sore it almost took my breath away. It felt like a constant cramp that lasted three days. I had difficulty sleeping for a few nights and started getting concerned that I was bleeding internally or something was wrong with my kidney, and of course, none of that was true. It was my muscles that were hurting – perhaps from my cramped position on the plane ride home. I treated myself to a one-hour massage from an oncology nurse at the hospital. I have been fine since.

• About five days into Cycle 4 I ate a couple tangerines and a tomato (apparently too much acid) and the inside of my mouth paid for it. I got two blisters on the bottom of my tongue and the inside of my entire mouth (including inside lips) is very tender and sensitive. I could hardly brush my teeth without it feeling like my gums were bleeding (which they did not). This lasted about five days.

• Three-fourths of the way through Cycle 4 I noticed a red neck rash. Part of it was shaped like a perfect triangle. I also have Rosacea, so perhaps it was that. It was gone by the second day.

• Had a running nose and sneezing that lasted two days.

• At the end of Cycle 4 after arriving in hotel, I noticed the top of my left hand was covered with little numerous tiny pinhead-sized purple or red spots, which are flush with the surface of the skin. These are called Petechiae and are tiny hemorrhages within the dermal or submucosal layers. They went away after two days.

Believe me, I can live with these minor irritations.

BLOOD WORK

• I am still without monocytes, eosinophils, and basophils, but that seems par for the course.

• My LDH (lactate dehydrogenase) is 250, which is higher than normal, which is (113-226).

HOPE

This miracle drug -- Ibrutinib – has given all of us hope. So much research in targeted therapy is underway. The next step is to get access to the drug after the trial is over.

HAPPY DANCE

I got my airline ticket to NIH! Doing the HAPPY DANCE!!!

I will post when I return...

OBSTACLE

NOUN obstacle (def) = something immaterial that stands in the way and must be circumvented or surmounted;

For example: "Lack of imagination is an obstacle to one's advancement"; "The poverty of a district is an obstacle to good education"; "The filibuster was a major obstruction to the success of their plan"; “Hurricane Sandy is an obstacle to Dr. La Verne getting her ibrutinib.”

If this wasn’t so serious, I would be laughing ‘til I cried. I not only have to fight cancer, but now Hurricane Sandy is headed right to the DC/Baltimore area, where my plane is supposed to land next week and my cancer treatment drugs need to be picked up. My last day’s supply is Thursday. Stay tuned…

Blog gadget update

I just added a new gadget to my blog called FOLLOWERS. I would love for my subscribers to use that gadget by clicking on the "Join this site" button, so that I can see who is following my blog. I have had over 1,000 people viewing my blog, but I don't know who you are unless you have posted a comment, emailed me personally, or if I have seen you in person. Thank you in advance.
-- LV

WORDS of WISDOM

I had the honor of attending Chaya Venkat’s last meeting at her house in Columbia, Maryland – that is, until she “gets her mojo back.” It was really worth my while staying longer in the East Coast after my medical appointment at NIH (National Institutes of Health).

Chaya, the chief science writer for http://updates.clltopics.org/, is a priceless patient advocate for leukemia patients with all different venues of CLL/SLL. She gives relentlessly to leukemia patients. She has been my personal virtual rock, since I was diagnosed with 17p deleted malignant B-cells that have run amuck. She has been our voice, the layman’s translator of academic medical jargon, and the inspiration for us to take control of our own health. She has been the empress of all dragon slayers, but has grown weary in the battle. Chaya has been wounded too many times with the deaths of friends. She has held thousands of hands, and touched thousands of hearts. Now her heart needs a little R&R and healing, so off to India she goes. There is not enough love and gratitude to give back to that lovely woman. I personally will be forever grateful. I pray every day that she gets her mojo back…

This blog posting is a summary of the meeting topics I found most interesting to me. I am hoping this will inform those who are caretakers, as well as those who are patients.

I. TOPIC 1: DECISIONS ABOUT YOUR CANCER TREATMENT

A. When you enter a clinical trial, be aware of the informed consent.

B. Once you make a decision, “do not look back and second guess yourself, because therein lies madness…” (a quote from Chaya)

C. The buck stops with you the patient. You won’t be handed information. Don’t take it personally. You must be your own advocate.

D. Understand that the suicide rate is the highest in the oncology field. It can’t be fun watching people die.

II. TOPIC 2: FCO vs. FCR vs. BR CHEMOTHERAPY

In summary, FCO appears to work better than FCR, and FCR appears to work better than BR for most CLL/SLL patients.

A. FCO (fludarabine + cyclophosphamide + ofatumumab)

Fludarabine (trade name “Fludara”) is a purine analog that relies on a p53-dependent mechanism for cell kill; therefore, it is not as effective for 17p deleted patients.

Cyclophosphamide is an alkylating agent.

Ofatumumab (Trade name Arzerra, older name Humax-CD20) is a fully human protein that attaches to the CD20 marker. With previously treated patients who were fludarabine refractory and Campath ineligible or refractory, ofatumumab did seem to work better than Rituxan in clinical trials. Ofatumumab hangs onto the B-cell longer.

B. FCR (fludarabine + cyclophosphamide + Rituxan)

FCR is often referred to as the “gold standard.” This frontline treatment has been used successfully for a number of years. This is not a cure, however, and most patients will relapse after seven years.

Fludarabine (trade name “Fludara”) is a purine analog that relies on a p53-dependent mechanism for cell kill; therefore, it is not as effective for 17p deleted patients.

Cyclophosphamide is an alkylating agent.

Rituxan (rituximab) is a monoclonal antibody that is often called “mouse juice,” since it is made from human protein and mouse protein. It attaches to the CD20 marker.

C. BR (bendamustine + Rituxan)

Bendamustine (Treanda) is a purine analog/alkylator hybrid agent.

Rituxan (rituximab) is a monoclonal antibody that is often called “mouse juice,” since it is made from human protein and mouse protein. It attaches to the CD20 marker.

III. TOPIC 3:  INFECTIONS

A. Bacterial infections

CLL/SLL patients get bacterial infections if they do not have enough IgG in their blood work. CLL cells cannot grow up to be healthy plasma cells. Pneumonia is caused by bacterial infections. Therapy will not help IgG. The only drug that has made IGG levels go up is Revlimid (Lenalidomide).

IgG can be replaced with IVIG ($10,000 per dose). Blood from as many as 10,000 donors could be used to make a single batch of IVIG. IVIG is a blood product that is in short supply. IgA and IgM cannot be replaced.

B. Viral infections:

T-cells work with viral infections.

C. Clinical trial eligibility:

If a patient has been exposed to Hepatitis C, he or she is not eligible to participate in most clinical trials.

D. People don’t die of CLL/SLL. They die of one or more of the following:

1. secondary cancers

2. side effects of cancer treatment

3. pneumonia

E. How to prevent infections:

1. Have your Vitamin D3 level checked by you GP. Remember that excessive Vitamin D is also toxic.

2. Chew Trident sugarless gum or any gum with XYLOTOL. It is a sugar alcohol sweetener used as a sugar substitute, and bacteria can’t eat it. It essentially starves your bacteria. Xylitol is actively beneficial for dental health, reducing tooth decay to a third in regular use, and has been shown to reduce the incidence of ear infections.

3. Get inoculated. Get a pneumonia vaccine as soon as you are diagnosed. It works for five years. The longer you wait to get this inoculation, the less chance you have of it working fully. Get a flu shot every year, even if it has less of a chance of working as the time from diagnosis goes by.

4. Break the habit of touching your face.

IV. TOPIC 4:  KINASE INHIBITORS and REVLIMID

A. Ibrutinib (PCI-32765):

This is the kinase inhibitor clinical trial in which I am participating. NIH says that the drug will be FDA approved in 2-3 years. Chaya believes it will be more like 5 years until it is commercially available.

A couple participants have reported iron deficiency and being anemic due to gastro intestinal bleeding. This is a micro leak in the G.I. track – essentially a small almost unnoticeable leak that adds up over time.

B. CAL-101:

24% of the participants on the kinase inhibitor trial are suffering from Grade 3-4 pneumonia, according to Chaya.

C. Revlimid (lenalidomide), a thalidomide analogue (which caused limb abnormalities in babies when used during pregnancy) has proven to be a disappointment in treating 17p deleted patients. Overall, it has caused 80% of participants to have Grade 3-4 hematologic toxicity.

V. TOPIC 5: BONE MARROW

A. Pancytopemia means that the bone marrow is dead. This occurs in late-stage CLL/SLL. Red and white cells, as well as platelets are drastically reduced.

B. The white blood cell count and ALC (absolute lymphocyte count), which is the sum of the B and T-cell counts, are not as important as the infiltration of the:

1. bone marrow

2. spleen

3. liver

4. and lymph nodes

C. These counts are important for bone marrow health:

1. red blood count (normal range 3.93-5.22 M/uL)

2. hemoglobin (normal range 11.2-15 g/dL)

3. neutrophils (normal range 34.0-71.1%)

4. platelets (normal range 173-369 K/uL)

VI. TOPIC 6: HEALTH TRIVIA

A. The basal temperature of a leukemia patient is abnormally lower than the normal person. If a healthy person’s body temperature is 98.6 degrees Fahrenheit, a leukemia patient can have a full-blown fever at 99 degrees.

Take your temperature the same time each day for 2-3 weeks and chart the results. This will be evidence to give your doctors to show your lower body temperature.

B. Dental care is very important for a CLL/SLL patient. Please inform your dentist that you are a leukemia patient. Let him or her know about your treatment and side effects.

C. Types of cytopenia:

1. anemia = a deficiency of red blood cells

2. Leukocytes, leucopenia, or neutropenia = a deficiency of white blood cells

3. thrombocytopenia = a deficiency of platelets

4. leukocytopenia = too low WBC

So these are the notes I wrote down at the meeting. These were the topics that were of particular interest to me. I hope you will find this information helpful to you.

Until my next posting … wishing you love and gratitude, because after all… we are all in this together.

SERENDIPITY

The big news is that as of October 4, 2012 the clinical trial at National Institutes of Health in Bethesda, Maryland (NCT01500733) has been suspended and is currently under review. This research area of the federal government is one of the most valuable resources for people like me who are left with little options. This means that the additional 17p-deleted leukemia patients, who thought they were new participants in the clinical trial, are temporarily on hold and are not allowed to be on the study until further notice. This does not include me, because I am not a new patient.

Professor Chaya Venkat, my patient advocate, met with the research director of Johnson & Johnson to try to get compassionate use of ibrutinib, since these patients will not live long enough for the drug to be FDA approved. She said she would pay her way to California to meet with the drug company stakeholders. She was denied.

It is also unclear whether untreated 17p-deleted patients (me) will be included in the initial FDA approval. The key is to get enough participants in the trial to have a decent enough sample size to warrant inclusion. Suspension of the trial is a big kick in the stomach. We are 5% of the CLL/SLL cancer population.

NIH will continue to follow patients in this trial and continue to provide the drug as long as the drug company provides the drug to NIH. NIH may continue to monitor patients after the trial.

I have written a letter to President Obama letting him know about the importance of the people who provide funding for the research. What is done here at NIH is of incredible value to patients. This is how medicine is suppose to be.

This posting is about my health update.

BLOOD WORK

The good news is that my white blood count (WBC) has dropped another 25,100, which is heading in the right direction. These are normal: electrolytes, kidney, liver, sodium, potassium, red blood count, hemoglobin (which means I am not anemic), and lungs.

These counts I need to keep an eye on:

Lactate dehydrogenase: slightly higher than normal

Uric acid: slightly higher

Platelet function: slightly lower

I have no eosinophils or basophils in my immune system.

Neutriphils are 9.5%, when they should be 34.0% to 71.1%.

BONE MARROW BIOPSY

According to Dr. Adrian Wiestner in the Hemotology Branch of the National Heart, Lung, and Blood Institute (NHLBI) of NIH, I have a very good reduction of malignant B-cells in my body and the experiment is going as expected. My bone marrow biopsy indicates lymphoid infiltration involving 20-30%, as opposed to 40-50% eight weeks earlier. Before the clinical trial, researchers knew that the drug would diminish the size of lymph nodes and eradicate the malignant cells in a patients’ blood through apoptosis (cell death). They were not sure it would help the bone marrow, in which much of the malignant cells hide out. Well, now we have a new scientific finding! It is working on the bone marrow too!

CD3 shows scattered positive T-cells. CD3 is required for T-cell activation.

CD34 protein has slightly increased to 3-5% positive. This is an important adhesion molecule and is required for T-cells to enter the lymph nodes. It facilitates cell migration.

I also have positive megakaryocytes, which are large bone marrow cells from which mature blood platelets originate.

CT SCAN

According to the CT scan, there is a decrease in adenopathy (swelling or abnormal enlargement of the lymph nodes) since June 20, 2012. In the September 7, 2012 report, there is evidence of lymphadenopathy, but the number and size of the lymph nodes on the neck have “dramatically decreased” when compared to several months prior.

The CT scan indicated degenerative disease in my neck of which I was aware. Prior to beginning the clinical trial, I was going to physical therapy at The Barrow Institute in Scottsdale. The attending physician had looked at my scans and thought he had pulled the wrong medical records when I entered his office. He said that if he had just looked at the medical scans, he would have said that I was a patient who had to immediately go in for spinal surgery. He said he was surprised at how good I looked. Surprise! But this is another story for another day…

MORE GOOD NEWS

In spite of the fact that I have had some minor side effects, such as slight bruising, a little dizziness, and occasional tenderness in my mouth, I have no breathing problems, no high blood pressure, no appetite issues, no mouth ulcers. I have had a little more fatigue the past cycle (even though my blood work does not indicate a reason for the fatigue). I think I was so excited that I was feeling better that I overdid it a little.

FINAL THOUGHTS

The researchers at NIH are pleased with my progress on this experimental drug. It seems to be doing what it is supposed to do. I am about as happy as an “egg-suckin’ dog in the middle of a chicken coop” (my husband Carl’s words).

One thing I understand is that even when my WBC is normalized (between 4,000 to 10,000). I will still be immune compromised since the drug does not cure me. It simply manages the cancer. Medicines that interferes negatively with Ibrutinib are the following: anti-fungal systemic pills, anti-depression medicine, acid reflux medicine, and blood thinners (a BIG no-no).

Being immune compromised also means that I cannot ever have inoculations with live viruses, such as a live shingle shot. I also cannot be around people who have had the live virus shot for about a week to 10 days. That also includes live virus inoculations given to my grandchildren, my dog, and people at the Walgreens Pharmacy.

When you are first diagnosed, you should have a pneumonia shot, which should last about five years. A flu shot should be given every year, even though it may not help a patient who has had leukemia for a while, but it might help a little.

Since the number one cause of death for patients like me is pneumonia, the herd mentality is in place here. If you have been inoculated and protected from whatever diseases and you are in good health, flock around me, because you will protect me from the germy people. LOL.

I personally will be eternally grateful for the opportunity I have been given to participate in the NIH clinical trial with Ibrutinib (PCI-32765), regardless of whether this experimental drug helps me in the long haul or regardless of whether I continue to have access to it. I know I am helping others in the future, who can benefit from the findings of this scientific research.