Four brain cancer treatment case reports are presented below. These are patients with recurrent brain malignancies who were treated with TVAX Immunotherapy. These cases are presented to illustrate the outcomes that can be achieved using TVAX Immunotherapy to treat cancers that fail to respond to any other treatment or treatment combination. The case reports are followed by a summary of the outcome data that were obtained using the most recently tested version of TVAX Immunotherapy.
Case Summaries
Case number one: The patient had a grade III astrocytoma that had progressed following standard surgery, whole brain radiation and chemotherapy. The patient's cancer then was treated with surgery and high dose chemotherapy followed by stem cell transplantation and again progressed. After that, a third surgery was performed and the cancer again progressed. At that time, the patient was treated with TVAX immunotherapy and received no additional treatment. The effect of TVAX Immunotherapy on the patient's cancer is shown in the Case 1 figure, below. The patient is still alive and disease-free today, more than ten years later. This case was included in a small phase I/II study of an early treatment version that was published in 2000. See complete publication.
Brain Cancer Treatment
Case number two:
The patient had a grade III astrocytoma that had progressed following
standard surgery, whole brain radiation and chemotherapy. The cancer
then was treated with a second debulking surgery that was immediately
followed with TVAX Immunotherapy. The patient received no additional
treatment. The effect of TVAX Immunotherapy on the patient's cancer is
shown in the Case 2 figure, below. The patient lived more than five
years disease free, at which time the cancer returned and the patient
died from his brain cancer. This case was included in a small phase
I/II of an early treatment version that was published in 2000. See complete publication.
Brain Cancer Treatment
Case number three:
The patient had a grade IV astrocytoma, which is also called
glioblastoma multiforme. The cancer had progressed following standard
surgery, whole brain radiation and chemotherapy. At that time the
cancer was treated with a second surgery that was immediately followed
with TVAX Immunotherapy. The effect of TVAX Immunotherapy on the
patient's cancer is shown in the Case 3 figure, below. The patient was
disease free for more than a year and a half following treatment with
TVAX Immunotherapy, at which time he was lost to clinical follow-up.
This case was included in a small phase I/II study of the most recently
tested version of the treatment that was published in 2000. See complete publication.
Brain Cancer Treatment
Case number four:
The patient had a grade IV astrocytoma that had progressed following
standard surgery, whole brain radiation and chemotherapy. The patient
then was treated with surgery and high dose chemotherapy followed by
stem cell rescue and the cancer progressed at which time the cancer was
treated with immunotherapy. The effect of TVAX Immunotherapy on the
patient's cancer is shown in the Case 4 figure, below. The patient
lived disease free for more than two years following treatment with
TVAX Immunotherapy, at which time she was lost to clinical follow-up.
This case has not been published.
Brain Cancer Treatment
Outcome Summary
Three increasingly potent versions of TVAX Immunotherapy have been tested for their safety and efficacy against recurrent grade III/IV astrocytomas, a type of untreatable brain cancer. The most potent and most recently tested version used the following protocol:
Patients were vaccinated twice two weeks apart with their own cancer cells and GM-CSF. Two weeks later, immune cells were collected from the blood and converted into large numbers of "killer" T cells. The "killer" T cells were then injected back into the patient's bloodstream. A small phase IIa study that included nineteen patients was performed to test the safety and efficacy of this treatment version. That study was published in the journal, Neurosurgical Focus1.
Eighty-nine percent (17/19) of the vaccinated patients developed immune responses against their own cancer cells. In addition, forty-two percent (8/19) of the patients had objective clinical responses (shrinkage of their cancers). An additional high proportion (9/19) of the patients exhibited clinically significant disease stabilization. Some of the patients experienced flu-like symptoms following vaccination and/or infusion of "killer" T cells, but those effects completely disappeared within hours or, at most, a few days.
These data demonstrated that TVAX Immunotherapy can have a significant positive clinical effect on some progressing human grade III/IV astrocytomas. Patients' cancers got smaller and patients' survival was significantly prolonged. There is no way to predict which patients will respond to the treatment or how great the response will be when the treatment is applied in the future. Obviously, there are some patients whose cancers were unaffected.
The studies described above should be viewed as preliminary studies designed to demonstrate proof of principle for the general treatment strategy and to determine an optimal delivery method. Exactly how safe and effective TVAX Immunotherapy could be against either recurrent or primary astrocytomas will not be known until well designed, randomized clinical trials have been performed. However, it is possible to say that there are no known cancer treatments that have produced anti-cancer effect that are comparable to those illustrated here. The treatment has been shown to be extremely safe and very effective.
Finally, in the same way that each of the TVAX Immunotherapy versions that have been tested heretofore have produced increasingly powerful outcomes, the studies that are currently planned and authorized by the FDA under the current TVAX IND will test a new and potentially improved treatment version that likely will safely produce even greater anti-cancer effects.
Three important changes will be implemented that would be predicted to increase treatment potency and correspondingly improve clinical outcomes.
Patients will be vaccinated with higher numbers of cancer cells. The greater the amount of cancer that the patient's immune system is exposed to, the greater the immune response.
Patients will be vaccinated more times (5 versus 2). Each booster vaccination should induce a correspondingly greater immune response.
Patients will receive systemic interleukin-2 following infusion of killer T cells. Systemic interleukin-2 should provide additional clinical benefit over and above the effects produced by infused killer T cells alone because interleukin-2 stimulates the infused killer T cells to multiply within the body.
These are hypotheses. There is no way to know how safe and effective this apparently safe, natural immunological cancer treatment could be without performing well-controlled human clinical trials.
1Sloan AE, Dansey R, Zamorano
L, Barger G, Hamm
C, Diaz F,Baynes RD, Wood GW.
Adoptive immunotherapy in patients with recurrent malignant
glioma: Preliminary results of using autologous whole-tumor vaccine plus
granulocyte-macrophage colony-stimulating factor and adoptive transfer of
anti-CD3-activated lymphocytes. Neurosurgical Focus 9:1-8 (2000)
