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 GLCI - MSU Breslin Cancer Center opens two Phase I Clinical
Trials…
Click here for the latest Phase 1 Clinical
Trials update at GLCI.
According to Dr. Barbara A. Conley, GLCI Associate Medical Director for
Translational Research, Hematology-Oncology Division Head and Professor of
Medicine at MSU, basic scientific research and Phase I Clinical Trials mean new
drugs for our community. The key elements include a need in the community,
funds, good research nurses, good principal investigators, and good medical
management and oversight. In July 2006, GLCI-MSU Breslin Cancer Center began two
Phase I Clinical Trials.
One of the two Phase I Clinical Trials now underway at MSU deals with
antigens, antibodies and molecular targets within a cancer cell. The
other involves an agent that is intended to target and interrupt a molecular
"signal" that causes a cancer cell to divide and invade other tissues.
The purpose of the first of the two trials is to determine if
- "the antigen" will produce antibodies,
- "the antibodies" will bind to the antigen,
- the antigen will carry the antibodies to the
"molecular target"at or in a cancer cell,
- this type of targeting will allow the body’s immune system to destroy the
cancer.
The theory is - if the antigens will cause the body to produce antibodies
that will attack the cancer cells, the antigen will train the body to destroy
the cancer at the molecular level.
As Dr. Conley explains: "Phase I has two purposes. One is to determine
whether or not the human body can tolerate the new drug/agent and how much the
body can tolerate (dose) before the risk and /or ill effects become intolerable
(toxicity). The second is to determine whether or not the new drug/agent acts on
the target. Does the agent or drug make it through the body to the intended
target and if so does it impact the target in any way? Any new agent or drug
that has 1) been studied and found to have promising activity in a test tube,
petri dish, or animal (that is already sick), and 2) can be prepared in a
formulation that can actually be administered to humans, could be considered for
a Phase I Clinical Trial. In Phase I the drug is usually given to people with
different types of cancers whose cancer has not responded to standard treatment.
The agent may reach the target in every case or none at all, and it may register
an impact in certain types of cancer cells and not in others. So part of the
purpose of Phase I Trials is to get a preliminary idea of which types of cancer
this new drug/agent might be used for. Only five to eight percent of all agents
in a Phase I Clinical Trial ever show enough promise to move to Phase II."
Phase II Trials study the way a specific type of tumor responds to the new
drug or agent. If an agent seems to be better than standard treatment, it may be
tested in a Phase III Clinical Trial to directly compare the new drug therapy to
the existing therapy (if there is one) and determine if the new one is better
than the standard or existing treatment.
There is a great deal of basic scientific research at MSU relative to the
molecular activity in cells, this research can translate to molecular
therapeutic and diagnostics tools. According to Dr. Conley targeted therapies
are not new, she sites Cisplastin, discovered at MSU over thirty years ago as an
example. However, the strategies are new and different. "Originally,"
Conley says, "we took the approach that giving toxic drugs could kill the tumor
and enough of everything surrounding it to get rid of the cancer, even though
normal cells and organs got the toxic drug too. If we could do this without
killing the patient, the patient should benefit. Today the goal is to
‘interfere’ with molecules inside or at the cancer cell, to prevent it from
going anywhere let alone dividing. If for example a person had a two-centimeter
cancer in their breast, but we could keep it from ever doing anything or
becoming anything more than a two-centimeter tumor in their breast, then the
tumor may not be a problem."
Conley says the key to conquering cancer is in learning how (at the molecular
level) and why (molecular activity) certain cells and molecules and genes
express themselves (signal one another to take certain actions). "If we can
understand these interactions and can find a way to target the molecules that
affect a broad range of signals, we can modify the signals and the actions
within the cell. If we can learn how to treat cancer so that the person not only
survives but also lives well and feels good in the process, cancer becomes a
chronic but manageable disease."
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