It’s an innovation in cancer treatment that’s relatively new, but the results have been encouraging, and trials in UKM Medical Centre using HITV to fight cancer are in progress.
A form of immunotherapy is showing encouraging results in the treatment of stage 4 and recurrent cancer patients.
In a public forum held last Sunday at the Kuala Lumpur Convention Centre, Dr Kenichiro Hasumi, founder of Hasumi International Research Foundation and innovator of the Hasumi Immuno-Therapeutic Vaccine (HITV), shared his clinical findings on the effects of HITV on patients with stage 4 or recurrent cancer.
He reported that the HITV protocol managed to achieve 80% complete regression in stage 4 cancer patients who fulfilled treatment criteria, i.e. not more than 10 metastatic tumours, with each tumour not more than 5cm in size.
The main thrust of HITV therapy is the use of dendritic cells to prime cancer cells to be vulnerable to subsequent treatment procedures.
Dendritic cells are a critical link in the immune system. Acting as sentinels, these cells “patrol” the body seeking out foreign invaders, whether these be bacteria, viruses or cancer cells.
After “capturing” the invaders, dendritic cells “cut” them into smaller pieces and display the antigenic fragments on their cell surfaces, converting these antigens into complexes that can be recognised by other cells of the immune system to mount a response and destroy them.
For orchestrating these various processes efficiently and precisely, the dendritic cells are considered to be “conductors of the immune orchestra”.
In HITV, dendritic cells taken and processed from the patient’s own body are injected directly into the tumour, the “vaccination” process. As the cells need to be injected into the tumour, HITV is only suitable for solid tumours.
The tumour is subsequently subjected to image-guided intensity modulated radiotherapy and CTL (cytotoxic T-lymphocytes) injections to kill off cancer cells.
In a report entitled Clinical response of advanced cancer patients to cellular immunotherapy and intensity-modulated radiation therapy, published in the journal OncoImmunology in 2013, Dr Hasumi and co-authors wrote that “patients afflicted with advanced cancers were treated with the intratumoral injection of autologous immature dendritic cells (iDCs) followed by activated T-cell infusion and intensity-modulated radiation therapy (IMRT).
“A second round of iDCs and activated T cells was then administered to patients after the last radiation cycle. This complete regimen was repeated for new and recurring lesions after six weeks of follow-up.
“One year post therapy, outcome analyses were performed to evaluate treatment efficacy. Patients were grouped according to both the number and size of tumours and clinical parameters at treatment initiation, including recurrent disease after standard cancer therapy, Stage IV disease, and no prior therapy.
“Irrespective of prior treatment status, 23 out of 37 patients with less than five neoplastic lesions that were less than 3cm in diameter achieved complete responses (CRs), and five out of 37 exhibited partial responses (PRs).”
According to Dr Hasumi, the antibodies and CTLs produced by this process are able to hunt for cancer cells wherever they may be hiding in the body. Once the immune system is able to recognise the identifying features of the cancer cells, it will retain the information for life and prevent future recurrences.
According to a patient who has undergone HITV, the procedure does not lead to significant side effects so commonly seen in chemotherapy.
Adds Dr Hasumi: “It is our goal to not compete but unite with other established therapies, to find the best approach to benefit cancer patients. We will be conducting numerous clinical trials in Malaysia, Japan, United States and other countries in the world.”
Two such trials are currently being carried out in Universiti Kebangsaan Malaysia Medical Centre (formerly known as Hospital Universiti Kebangsaan Malaysia) in Kuala Lumpur.
One involves breast cancer, while the other is a lymphoma trial.
Prof Dr Norlia Abdullah, from the Department of Surgery at UKM Medical Centre, who also spoke at the forum, is heading the breast cancer arm of the trial.
At the public forum, she shared some of her experiences with the HITV trial, and listed out the requirements for patients who qualify for the trial.
The inclusion criteria include the following:
1. At least 18 years old
2. Histologically confirmed invasive ductal carcinoma of the breast
3. Her2 negative (IHC <2+ / FISH negative)
4. Local and/or metastatic breast carcinoma with metabolic activity <4cm
5. Progressive disease on or after second line chemotherapy
6. Patients who clinically require chemotherapy but refused
7. Patients who clinically require chemotherapy but are unsuitable for chemotherapy
8. A maximum number of 10 lesions. These lesions must be deemed accessible and safe to be irradiated by the oncologist and to be injected by the interventional radiologist.
9. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
10. Life expectancy of a minimum of six months
1. Her2 3+ positive (amplified)
2. Pregnant & lactating women
4. Autoimmune diseases (eg systemic lupus erythematosus)
5. Other malignancies
6. Central nervous system metastases
7. Pericardial effusion, pleural effusion or ascites
The lymphoma trial in UKM Medical Centre is a prospective Phase II clinical study involving 20 patients with refractory/relapsed lymphoma. The study population will be comprised of two arms – control arm and test arm.
The inclusion criteria is as follows:
1. Patients with histologically confirmed lymphoma according to WHO criteria who have failed salvage therapy
2. Measurable tumours with a minimum diameter of 2cm or metabolic activity, as measured by PET-CT at a standardised uptake value, background ratio of >1:5
3. Age between ≥18 to ≤75years
4. Refused chemotherapy or unsuitable for chemotherapy
5. A maximum number of 10 lesions as long as these lesions are deemed accessible and safe to be irradiated by the oncologist and injected by the interventional radiologist.
6. A minimum lapse of three months from prior therapy to date of study enrollment
7. Adequate organ function
8. Eastern Coorperative Oncology Group (ECOG) performance status ≤ 2
1. Life expectancy less than three months
2. Evidence of severe lung, heart, liver, or renal failure or severe neurologic disorder
3. Presence of autoimmune disease or atopic allergy
4. HIV positivity
5. Active hepatitis B, C infection
7. Other malignancy
8. CNS metastases
9. Psychiatric disorder
The forum, entitled “The role of immunotherapy in the treatment of cancer”, was jointly organised by HITV Laboratory and PRIDE Foundation Malaysia.
PRIDE Foundation is a charity body that aims to enhance awareness and improve accessibility to treatment and care of breast cancer patients in the country.
The Hasumi International Research Foundation is a non-profit organisation based in the US which conducts and supports scientific research in connection with finding a cure for various forms of cancer, particularly with the use of immunotherapy.
For further information about HITV, email email@example.com.