What is it?
This is an online clinical trial in which the most
promising anti-tumor and/or anti-angiogenic and/or immunologic chemotherapy
treatment is selected for each patient using the Microvessel
Viability Assay (MVV) along with with functional tumor cell (cellomic) profiling.
Why is this study being
posted online in real time?
In most clinical studies, progress is kept
secret for months or years. In
fact, the results of most clinical trials are never published.
A survey of 2,028 clinical trials was conducted by researchers at the
Of clinical trials
registered with the NIH (National Institutes of Health) after September 1,
2004, only 11.9% ever were published in peer-reviewed literature.
Among those clinical trials sponsored by industry as
opposed to those sponsored by government, only 5.9% were published.
The authors of the survey report concluded that a major reason for not publishing
results of a particular study is that the results of that
study were not positive. Even so, among those studies that
actually were published, only 64.5% reported positive
findings. This highlights the
fact that thousands of patients enter clinical trials annually, almost
certainly hopeful for some clinical benefit but at least expecting that their participation in
the study will help future cancer patients.
The statistics show that this expectation often is misplaced.
Therefore, this study is being published
online in real time so that any cancer patient who is considering entering
the study will know in advance if other patients have been helped in a
meaningful way by their participation.
Further, physicians will know in advance if this clinical trial is one which
they can recommend to their patients, even though the doctors themselves
will not be paid for enrolling patients, as they are in many other clinical
trials.
Finally, cancer patients, cancer physicians, and those who plan, fund, and
carry-out clinical trials will learn from the successes and/or failures of
this clinical trial and will be able to put the knowledge gained from this
study to work today rather than having to wait years to learn the results –
or never.
What makes this study different
from other clinical studies involving functional tumor cell profiling which previously
were reported in the medical literature?
This is the first clinical trial in which
anti-angiogenesis drugs, new-generation anti-EGFR and other targeted therapy drugs, standard
cytotoxic and cytostatic drugs, and biologic response modifiers, are tested
for activity as single agents and in rational combinations specifically
against living tumor cells obtained from each cancer
patient in the trial.
This is the first clinical trial in which the
endothelial cell-based microvessel viability (MVV)
assay is combined with functional tumor cell profiling.
This is the first clinical trial in which it is
possible to discriminate anti-tumor drug effects from anti-angiogenesis drug
effects in advance of treatment, allowing for the identification of drug regimens
which potentially could enhance both effects.
In this clinical trial, each
patient receives the treatment which is designed for him or her alone.
In most trials, patients are randomly assigned to receive one of two or
three drug regimens which are standardized for all trial participants.
These drug regimens generally are selected because one or more of them is of financial or
academic interest to the
pharmaceutical company or institution which is sponsoring the trial.
This is the first clinical trial we are
aware of in which results are
reported in real-time so that patients will be able to assess the probability
that they will derive benefit before deciding whether or not to enter
the trial.
With most trials, several years pass before patients and physicians
are given any clue as to the results.
Why are there no other trials
involving individualized combinations of anti-angiogenic agents?
The microvessel viability MVV assay is the first
practical, live-cell-based test to be reported that
allows for selective testing of anti-angiogenic drug combinations in human
cancer. Until recently, no technology existed which allowed for
individualized laboratory assessment of candidate anti-angiogenic, EGFR
targeted, and standard cytotoxic drug combinations prior to
administering them to patients.
The MVV assay was invented by Larry Weisenthal, M.D., Ph.D., Medical and
Laboratory Director of Weisenthal Cancer Group and is based upon his
discovery that endothelial cells are present in clusters of live tumor cells
obtained from individual cancer patients.
The discovery is reported in the
Journal of Internal Medicine.
(Click on the link.)
Who is eligible to participate
in the clinical trial?
The study candidate must have a diagnosis
of cancer.
The study candidate must have tumor cells
that are available through biopsy.
The study candidate must be well enough to receive
chemotherapy.
The study candidate have the ability to pay for his or her testing and non-covered treatments without incurring financial hardship.
Will medical insurance pay for
my treatments?
Perhaps but there is no guarantee. For some patients, treatment may involve drugs which are
not covered by insurance in certain disease
settings.
It is also possible that other aspects of study, such as laboratory tests and/or surgery or biopsy procedures, will not be
eligible for insurance coverage.
How can I learn more about the
trial?
Call or email Weisenthal Cancer Group and ask to speak with Connie Rueff, Study Coordinator. She will answer any questions you may have and will help you to determine if you are a candidate for entry. (714) 596-2100 or mail@weisenthalcancer.com.
