Glioblastoma Multiforme Clinical Trial
Official title:
Phase I/II Study of ZD6474 (Vandetanib) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma
Phase I:
The purpose of this research study is to determine the safety of the combination treatment of
ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,
temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment
of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given
safely when combined with temozolomide (Temodar) and radiation therapy.
Phase II:
The purpose of this research study is to determine the efficacy of the combination treatment
of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,
temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment
of glioblastomas.
All subjects participating in this research study must NOT be taking a certain type of
anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but
are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and
trileptal.
Currently the standard treatment for glioblastomas and gliosarcomas is temozolomide (Temodar)
and radiation therapy. This study is being done because research has shown that glioblastomas
have genetic changes that may cause an excess of certain cell growth factors and their
receptors, which can cause uncontrolled tumor growth. The drug being used in this research
study, ZD6474 (Vandetanib), is designed to block the receptors to two of these growth
factors, the vascular endothelial growth factor (VEGF) and the epidermal growth factor (EGF).
These growth factors are important in pathways that promote tumor growth and increasing blood
supply to the tumor. Blocking these receptors may reduce the blood supply to the tumor and
help slow down tumor growth. There is also laboratory evidence that blocking these receptors
may increase the sensitivity of glioblastomas to radiation therapy.
This research study is a Phase I/II clinical trial.
Phase I clinical trials test the safety of an investigational drug. Phase I studies also try
to define the appropriate dose of the investigational drug to use for further studies. We
will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined
with temozolomide (Temodar) and radiation therapy.
The purpose of Phase II of this research study is to determine the efficacy of the
combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and
gliosarcomas, temozolomide (Temodar) and radiation therapy. It will look to see how patients
fare on treatment (if they progress and when, how they are doing after 12 months of
treatment). In this research study, the safety of the combination treatment of ZD6474
(Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide
(Temodar) and radiation therapy will be further evaluated. We will also be looking at samples
to see if there are correlations between them and how well patients do on treatment.
This agent is investigational for the treatment of glioblastomas. "Investigational" means
that the drug is still being studied and that research doctors are trying to find out more
about it. It also means that the FDA (U.S. Food and Drug Administration) has not approved
ZD6474 (Vandetanib) for use for your type of cancer. All subjects participating in this
research study must NOT be taking a certain type of anti-seizure medication called enzyme
inducing anticonvulsant drugs. These drugs include the following medications: Dilantin,
Tegretol, Phenobarbital and trileptal.
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