ANBL - 32 Clinical Trial; Post Primary Protocol

Abdullah is now a a candidate for a phase 3 immunotherapy clinical trial. This is the hardest decision making we are faced with yet in the treatment of our child. How can one rationalize to put their child through another 6 months of hospital, with at minimum a lot of pain, not knowing whether or not this trial will be beneficial in any way.

Description:
This study is being done to determine if monoclonal antibody Ch14.18 + cytokines + isotretinoin (13-cis-retinoic acid or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone in high risk patients with neuroblastoma who have achieved a pre-ASCT response of CR, VGPR, or PR. Patients will be randomized into one of two treatment arms (Regimen A or Regimen B). Patients in Regimen A will receive the drug cis-RA approximately 2 months following stem cell transplant. Patients begin 6 monthly treatments with 13-cis-retinoic acid and will take this drug by mouth twice a day for 14 days and then not take it for the following 14 days. This 28-day course will be repeated 6 times. Regimen B involves treatment with cis-RA as well as the experimental agent, C14.18, GM-CSF, and IL-2. Regimen B is given over six 28-day courses; there may be different combinations of drugs in the courses.

Criteria:
1. Patients must have a confirmed diagnosis of neuroblastoma, and categorized as high risk at the time of diagnosis. 2. Patients must not be older than 30 at diagnosis. 3. If patient is enrolled in study A3973, then the patient must have completed front-line therapy followed by ASCT and radiotherapy as outlined in A3973, AND have achieved CR, VGPR or PR at pre-ASCT evaluation. 4. If a patient is not enrolled on the study A3973, the patient will be eligible for this study if they are CR/VGPR/PR after treatment with one of the study designated induction regimens prior to a single cycle of high-dose therapy and ASCT. 5. No later than 9 months from the date of starting the first induction chemotherapy after diagnosis to the date of autologous stem cell transplantation should elapse. 6. Patients must not have progressive disease or biopsy proven residual disease if not enrolled on the study A3973 at the time of enrollment in this study. 7. Patients must have adequate renal, liver, cardiac, pulmonary and central nervous function.

Stem Cell Transplant

The high dose chemo had clearly taken its toll on Abdullah. He had lost his skin coloration, looked like a bruised kid with dark patches all over his body. I would say he looked similar to how he looked after his 1st chemo. He seemed neutropenic today, he probably was as his wbc count was 0.8 today. He was sneezing pretty often.

His schedule for the day a laid out clearly by his nurse in the morning.
11 am; He was given a bath with some special chemicals to disinfect his body completely. He was then taken to a new clean air flow isolation room with an even greater pressure, room # 11 in unit 8B.
2 pm; He received just 40cc of his own tem cells in a transfusion that just lasted 20 mins. The procedure was simple enough, nothing very complex contrary to the general perception.

I guess stem cell transplants from ones own stem cells are simpler to carry out than bone marrow transplants from 3rd party donors. We did receive may phone calls asking whether the procedure went fine. Its not the procedure which causes the complexity, but its the super depressed immnue system, the extended neurtopenia due to the almost dead bone marrow (because of the high dose chemo) which causes the complexity. The below link gives more info on the stem cell transplant at the bone marrow unit; http://www.nhlbi.nih.gov/health/dci/Diseases/bmsct/bmsct_all.html

Abdullah wasn't talking to me , as he was pretty down because of the stong side effects of the high dose chemo. Infact he was recalling the mucusitus he had in the 1st round as he was probably experiencing the onset of the mucusitus this time round again. Mucusitus is a pretty horrible condition with no treatment. Sores in the lining of the mouth, throat, gut through to the anus. He couldn't even take in his own saliva and was drooling for period until neutrophils returned the 1st time around. We are expecting something similar this time around.

A more alaraming thing that happened post transplant was a new side effect from the transplant. High blood pressure and heart rate. He was give an oral medication which instantly reduced the blood pressure at 4 pm. Seemed to work pretty well. I was pretty content. I left for home early today @ 7pm as there was just 1 chair (used by asma) in the isolation room, and I wasnt allowed to sit on my sons bed. I also had to wear a new sanitized medical gown and mask while in the room, everytime I entered. I reached home @ 8pm and found out that Abdullahs high blood pressure and heart rate had returned. The docs and nurses were having a tough time bringing it down. They finally decided to give him lassex to reduce the blood pressure by lowering the fluid levels in his body.

I am mentally exhausted and would be going to bed early tonight.

Chemotherapy Round 7: High Dose

Abdullah has finished his high dose chemo yesterday! This intense chemo round lasted 96 hours.
His weight was ~15kg before the high dose chemo, today it came down to 13.2kg.

Hes been put on ambizone for anti fungal treatment, as the docs suspected some fungus in his nose from the cultures take earlier. The ENT team was now directly involved the very first time. They were brought in the resolve the suspected fungal infection issue, as the possible fungus could easily spread to the rest of the body. A possible plan is to remove the fugus infected tissue under anesthesia.

I got back from Dubai on Friday afternoon and went straight to the hospital. My son came running and hugged me. Within half a hour, a nurse came in to tell us that he had to go for another CT, this time of the nose and sinus. I took him for a CT scan of his nose and sinus to check again for the suspected fungal infection.

He is currently on anti biotics, anti fungal drugs and anti virals.

The doctors plan to start his stem cell transpant on Tues 22, April, 2008.

The plight of Neuroblastoma cancer patients, in search for a cure

Depressing <7% cure statistic for bone metastatised neuroblastoma cancer

I received this post on my neuroblastoma mailing list. Information seems pretty recent. Have posted the contents to my neuroblastoma information research blog. Will hopefully review and understand this information with Dr Beracheul on Wednesday.

All of a sudden this info has changed my mood from optimistic to depressed, even after all the progress we have made so far.

post: curcumin-induces-apoptosis-in-human

Blood Work because of low platelets

We arrived at the hospital at about mid day.

Abdullah got his blood work done; the platelets were in the 30s today, i.e. the count were improving. His wbc count was over 10 and hemoglobin was in the 90s. All was good. No platelet tranfusion required.

He was now off gcsf , needed no more pokes. The nurse tried to heprenize his CVL the yellow one worked but the blue refused to flush. They were going to send us of for an xray to ensure that the CVL was in the right place, when I requested the nurse to push and pull a little harder. Abdullah raised his hands and started singing and his line started working. Lucky us no need to take him for the xray. Though I realized that if the home care nurse would be unable to flush we would have to go back to the hospital to do that x ray and potentially have to spend another day at the hospital.

Abdullah bought a R/C helecopter from the toy stalls in the lobby and we went back home.

We were at the hospital for 7 hours, and the entire trip was slightly over 8 hours. We left the house at 11:00 am and got back home at 7:30 pm.

MIBG Scan

My son had his MIBG scan today. Thank God that it showed no more neuroblastoma in the child. We got the result 3 hours after the scan. I guess writing an all clear report is easier than writing a report hilighiting issues.

I was going to arrive at the hospital in the afternoon, post scan procedure. This was a stressful test for us the parents as it would most likely show the neuroblastoma peresent still in the child's body.

I arrived @ the hospital at 14:00, and discovered that my wife and child were still with the nuclear medicine team doing the MIBG. It had been 2 hours. In my subconscious I thought there was something wrong.

My son came out of the scanning room after about 30 mins. He was really excited to see me. Well atleast he was done with 1 more test. Now it was just the bone marrow aspirate, bone marrow biopsy and CVL line change procedure remaining before the high dose chemo on the 14th/15th April, 2008.

My wife really wanted to go home, as she had been in hospital for over 2 weeks now so she negotiated to reschedule the bone marrow tests and cvl procedure to be done next week instead of tomorrow. The doctors willingly agreed as the childs platelets were less than 20. This would give him enough time to start producing enough platelets.

Abdullah got discharged and was understandably very excited to go back home. However we had go back to the hospital the next day to check his platelets again.

Radiation Therapy Meeting

Today we had a meeting with the radiation doctors at Princess Margret Hospital close to the SickKids facility.

The meeting was to discuss the outline of Abdullah's radiation plan based on all the information so far. The doctors are planning 12 radiations to the left side of his belly and spine. The area potentially to be covered on the belly would be approximately 15cmx15cm.

The produre would require a cast created specifically for the contours of Abdullah, so that the radiations can be applied accurately and would be x-ray guided.

Abdullah would be awake during the produre, but alone for the period of time when the radiations are applied. The procedure length would be approximately 30 mins.

It would happen consectively every day at Princess Margret Hospital for 5 days in the 1st week post transplant, 5 days in the 2nd week and 2 days the following week.

The doctors explained the short term and long term side effects of the radiation.

Short term side effects;

• Nausea and vomiting
• Loss of appetite

Long term side effects;

• Left side would be shorter than right. Slightly but visible.
• His height would be about 2 inches shorter than his actual height, because of the radiation on his spine.
• Atleast half of his left kidney will lose function as it would radiated. The function will automatically be compensated by the other kidney.
• ~10% cases develop secondary tumors.

I signed the consent form today which would allow this procedure on my child post transplant. It is such a contradiction trying to cure by poisoning, that too trying it with a child who doesn't understand or know that certain things in his future are being written off to preserve his today. I hope he will understand our obligations to preserve his life under these circumstances.