A Phase IB Study of Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor
- The vaccines created from the participants melanoma cells are scheduled to be given to
the participants on days 1, 8, 15, 29 and every two weeks after until the supply of
vaccine has run out. The amount of vaccine is dependent on the total amount of cells
yielded when the tumor is processed and treated. It is hoped that participants will
receive at least six vaccines.
- The vaccines will be administered in two injections that will be placed underneath the
participants skin. The two injections will be given at the same place on the body.
- If tumor sample yields enough cells, participants will also receive an injection of
non-transduced irradiated melanoma cells. The purpose of this is to measure the amount
of reaction of the participants immune system occuring created by the vaccine.
- If either the vaccine site or DTH placement site has shown a reaction, a punch-biopsy
will be taken. This will consist of a small piece of skin tissue removed under local
- With vaccine #5, participants will receive a second DTH injection. Two days after the
vaccine and DTH injection, punch biopsies will be taken of both sites.
- At week 10 of treatment (or earlier if necessary), participants will undergo a chest,
abdomen and pelvic CT scan. The physician may also have participants undergo a brain
MRI if indicated at this time.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the doses of lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete CM-CSF that can be manufactured in stage III melanoma patients.
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|