Patients with incurable follicular non-Hodgkin’s lymphoma may find new
hope in a unique study involving the University of Nebraska Medical Center.
UNMC is the first of 23 cancer centers in the country to participate
in a clinical study assessing whether cancer vaccines, tailor made for
the patient, elicit a specific immune response against the patient’s lymphoma.
“This type of lymphoma is incurable with standard chemotherapy so we’re
trying to keep patients in remission longer by adding the vaccine to their
therapy,” said Julie Vose, M.D., professor of internal medicine – oncology/hematology.
The study is an extension of an earlier trial, in which UNMC and Stanford
University were the sole participants. In that phase, patients with follicular
lymphoma had a biopsy of their lymph node prior to treatment. The biopsy
was sent to Genitope Corporation in Redwood City, Calif., a biotechnology
company, which develops customized cancer vaccines for the patient using
a recombinant DNA technology.
“We were fortunate to participate in Phase II of the trial,” said Dr.
Vose, who is principal investigator on the study with Ronald Levy, M.D.,
professor of medicine at Stanford University School of Medicine. “Recombinant
DNA technology is a new way to make the vaccine. They essentially cloned
the tumor to produce a vaccine for the patient.”
Genitope Corp., the trial’s sponsor, genetically engineered the tumor-derived
vaccine to actively recruit the patient’s immune cells against the tumor,
leaving other cells unharmed. In general, the body doesn’t recognize lymphomas
or cancer as being a foreign substance. By changing the make-up of the
cancer, researchers hope the body recognizes the need to attack, rather
than accept, it.
Researchers hope the patient-specific immunotherapeutic approach will
help treat the more than 25,000 patients newly diagnosed with follicular
non-Hodgkin’s lymphoma each year in the United States.
Preliminary data from the UNMC/Stanford study was presented earlier
this month at the 42nd annual meeting of the American Society of Hematology.
According to the data, seven of 10 patients demonstrated specific immune
responses to the vaccine, meaning their body recognized the cancer as foreign.
Patients in the study received standard chemotherapy to put them in remission,
followed by a series of vaccinations.
“Our novel platform technology allows us to rapidly generate custom-made
proteins to combat tumors,” said Dan Denney, Ph.D., chairman and chief
executive officer of Genitope Corporation. “Based on the strength of these
data, we have launched a multi-center randomized Phase III trial to assess
the long-term disease-free survival of B cell non-Hodgkin’s lymphoma patients.”
Over the next two years, UNMC, along with other medical centers will
enroll 400 patients in the Phase III of the study. “This will allows us
to see if we need a biopsy of the patient’s lymphoma,” Dr. Vose said.
In this study, two-thirds of the patients will receive the custom made
vaccine and one-third of the patients will receive only the non-specific
immune stimulants following chemotherapy.
“This will allow us to evaluate the need for the custom made vaccine
or if non-specific stimulants of the immune system will be adequate to
generate the anti-lymphoma effect,” Dr. Vose said.
For more information, or to participate in the study, call Maribeth
Hohenstein at 559-9053.