Solid Tumors Clinical Trial
Official title:
GOAT; Phase I Single-Center Open Label Dose Escalation Study of CGTG-102, a GM-CSF Encoding Oncolytic Adenovirus, for Therapy of Advanced Cancers
Oncolytic viruses are viruses that can be found in nature, but they have been modified so
that they can no longer multiply in normal cells. These viruses "infect" cancer cells and
kill them. Once the cancer cell dies thousands of the viruses are released and can
potentially infect other cancer cells in the area. The effects of oncolytic viruses on the
tumor are felt to be the result of a combination of the oncolytic viruses directly killing
the tumor cells as well as the patient's immune system killing cancer cells that are
infected with the oncolytic virus.
Modern oncolytic viruses have been used for treatment of thousands of patients. The safety
of such treatments has been good and there have been no deaths caused by treatment with
oncolytic viruses. Many patients have benefited from the treatment in the sense that their
tumors have stopped growing, become smaller or even completely disappeared. Some benefits
are temporary, but about one third of patients seem to gain longer lasting benefit likely to
impact survival. The effect of oncolytic viruses on improving survival has not been
demonstrated yet.
Oncolytic viruses can be created from many different types of viruses. In this study the
investigators are using an oncolytic virus created from an adenovirus. Adenoviruses are the
types of viruses that cause the common cold and the flu. Because replication in normal cells
does not take place, these oncolytic viruses should not cause any diseases in normal cells.
Further, to date there has been no incidence of passing the virus on to other humans from
patients who were treated with oncolytic viruses.
The purpose of this study is to see the highest dose of CGTG-102 (the oncolytic virus being
used in this study) that can safely be given to subjects. The investigators will also
evaluate whether or not the CGTG-102 is helpful in reducing the size of the cancer and
improving patient survival.
Pre-treatment visit - subject will undergo a physical examination with vital signs, a blood
sample will be taken and a PET (Positron emission tomography)-CT (Computer tomography) scan
will be performed.
Thereafter, there will be 4 visits with injections performed on trial days 1, 4, 8 and 15.
TREATMENT:
The injections are given directly into the tumors with help from using an ultrasound. The
total dose of oncolytic virus the subject will receive will be divided into 1-10 injections
which will be injected into individual tumors in the body. The maximum number of tumors that
can be injected for one treatment will be 10 tumors.
STUDY VISIT 1:
On the day 1 visit, blood samples will be taken as well as two biopsies from one of the
tumors. In addition pleural fluids (fluids from the chest) or ascites (fluids from abdominal
walls) may be collected if possible. Then the subject will receive the first set of
injections with CGTG-102. Before the injections, the subject may be given a dose of Tylenol.
STUDY VISIT 2:
On the day 4 visit, in addition to blood samples being taken the subject will receive a
second round of intratumoral injections into the same tumors selected for injections on day
1. Urine will also be collected right before the subject goes home.
STUDY VISIT 3:
The day 8 visit is identical to the day 4 visit. The same blood samples and urine sample are
taken.
STUDY VISIT 4:
On the day 15 visit blood samples and a urine sample will be taken as well as a biopsy from
one of the tumors.
Subjects will have to stay overnight at the hospital after each treatment.
FOLLOW UP:
A follow-up visit will be scheduled on days 29 where only blood samples and a urine sample
will be taken.
The end of trial visit is scheduled around day 43 where in addition to lab samples a PET-CT
scan will be performed.
Following day 43 the subject will be contacted by study staff at 6 week intervals for 3
months, then at 3 month intervals for up to one year and yearly thereafter.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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