September 26, 1995
FDA expands access to experimental treatment for advanced renal cell cancer
FDA has allowed expanded access to a new technology involving
autologous somatic cell therapy for metastatic (stage IV) renal
cell cancer. This is the first somatic cell therapy administered
under FDA's treatment IND regulations. The following can be used
to answer questions.
Somatic cell therapies use living cells, processed outside the
source, for the prevention, diagnosis or treatment of diseases or
injuries. In this case, the manufacturer, Cellcor Inc., Newton,
Mass., extracts white blood cells from patients with advanced renal
(kidney) cancer, stimulates the cells, and reintroduces them into
the patients in order to help augment their immune systems. The
manufacturer calls the treatment "autolymphocyte therapy," or ALT.
FDA has established a process called the treatment IND for
patients suffering from serious or life-threatening conditions who
have exhausted established treatments or for whom no satisfactory
treatment exists. This process allows them to obtain promising
experimental drugs that have undergone sufficient clinical testing
to show that they may be safe and effective. In this case, FDA has
granted expanded access to ALT based on clinical data that
indicated that the activated somatic cells may decrease tumor size
with few serious side-effects in a small percentage of patients.
Currently, the only other approved treatment for metastatic
kidney cancer is interleukin-2 (Proleukin), manufactured by Chiron
Corp. However, some patients cannot tolerate interleukin-2's side
effects or do not respond favorably to the drug. This newly
approved treatment protocol offers seriously ill patients another
Cellcor Inc. will begin accepting patients for autolymphocyte
therapy in a few months. The company is permitted to recoup costs
for the treatment. Patients and health care professionals can
obtain more information about the treatment IND and its enrollment
criteria by calling Cellcor at 1-800-441-7901.
back arrow on your browser to go back (faster) or
click on the arrow to go back to the home page.