ANNOUNCER: There are times when medicine offers up hope for an advance that might change the course of a disease. Such is the case with Non-Hodgkin's Lymphoma and a new vaccine therapy which Doctors hope can prolong remissions and extend survival.
RONALD LEVY, MD: Chemotherapy and radiation therapy. The standard treatments can make the tumor shrink, can make it go away, but it's temporary and it eventually does come back. And this vaccine (we hope) will keep it from coming back.
ANNOUNCER: Non-Hodgkin's Lymphoma, a cancer of the immune system, is particularly suited to a vaccine.
DAVID FISHER, MD: We know that antibodies attack things and help us with our immune system. Everyone's lymphoma has a specific antibody, because all the cells are produced as a clone, they're all the same, because they're cancer cells. We call that antibody idiotype.
And every patient has a unique idiotype. You have to sort of put a flag on those cells and help the body recognize that those are indeed unwanted cells. We can take tumor cells, we can pull out the idiotype antibody, we can purify it and we can give it back to the patient to work as an immune booster, sort of like a vaccine.
RONALD LEVY, MD: It's kind of like using the immune system to go after the immune system. It's fighting fire with fire in a sense
ANNOUNCER: What's innovative about this approach - personalized immunotherapy - is that that the vaccine will be individualized - made for each patient from his or her own tumor cells.
RONALD LEVY, MD: The vaccine is custom-made for each person, from their own tumor. And it's only usable in that one person. So it's made from their tumor, from their own tumor cell and it's given back to them and they're the only one that can benefit from this vaccine that's made from their own tumor
ANNOUNCER: For any new therapy, a series of trials must be done.
DAVID FISHER, MD: Phase I is where we give a drug and we just look to see if it's safe. Phase II is we start to use the drug with a dose that we think that is safe based on the phase I trials and look to see is there any evidence of activity.
ANNOUNCER: Several Phase II trials of vaccine immunotherapy are ongoing. Results from completed Phase II trials were very promising.
RONALD LEVY, MD: We saw from those phase II trials that patients can make an immune response against their own tumor, and that they can stay in remission a long time, and that it's even better if they make that immune response. Not all of them make an immune response, the ones who do, have an exceedingly long time staying in remission and staying alive.
ANNOUNCER: The vaccines in the completed Phase II trials are now in phase III trials, the final step before a drug is approved. One Phase III trial is sponsored by a company named Genitope and a second, by the National Cancer Institute.
RONALD LEVY, MD: We have some people getting the vaccine that's made from their own tumor, and some people getting something that looks and feels like the vaccine but doesn't contain the ingredients from their own tumor. And we're comparing these two groups to each other. We're trying to prove that it actually keeps the lymphoma from coming back and keeps people living longer.
ANNOUNCER: Patients are still being recruited for these trials, but only certain patients are eligible.
DAVID FISHER, MD: The current trials are looking at patients with newly diagnosed follicular lymphoma. We're looking at patients who are newly diagnosed, so that they haven't been sort of beaten up with the chemotherapy and they have a good immune system.
RONALD LEVY, MD: We also like to have the tumor down to the minimum, so the tumor is not damaging the immune system.
ANNOUNCER: Two Phase II trials are looking at combining two immunotherapies, an antibody, called Rituxan, with the idiotype vaccine. This is an option for patients who don't respond as well as they might to the chemotherapy, who relapse, or even as their first treatment.
RONALD LEVY, MD: For the people who have what we call an inadequate response to chemotherapy (their tumors shrink not enough or they shrink not long enough and come back again) -- give all those patients Rituxan as a second treatment to get their tumors to shrink, and then to give them the vaccine.
ANNOUNCER: For patients in the Phase III trials, treatment follows a standard plan with an important addition.
DAVID FISHER, MD: We do require a biopsy of fresh tissue either a surgical biopsy or a needle biopsy. We do go through chemotherapy after that and the chemotherapy is standard and routine and it's the same you'd receive even if you weren't on the trial.
RONALD LEVY, MD: We allow a period of recovery from the chemotherapy for the immune system to recover before we start the vaccine.
DAVID FISHER, MD: The vaccinations are given as a shot under the skin like a diabetic gives himself insulin and it's been very well tolerated.
In addition, patients take a drug called GM-CSF as a shot under the skin for four days after each vaccination. This helps stimulate the immune response.
ANNOUNCER: The side effects from the vaccine itself are minimal.
DAVID FISHER, MD: You can sometimes get some redness, some swelling around the sites of the injections. Some people have had some flu-like symptoms, sort of muscle aches, low-grade fevers. Otherwise, they've been well tolerated.
Once the vaccinations are done, we follow patients, which is the standard of what we would do with patients who were receiving chemotherapy watch for any signs of recurrent disease, but without any further therapies.
ANNOUNCER: Yet taking part in the trial doesn't mean abandoning other therapies if the disease returns.
DAVID FISHER, MD: The question is: Does receiving the vaccine close any doors down the line? And it doesn't. So once the disease does show evidence of coming back, if it does, patients can receive any other therapy that they would if they hadn't received the vaccine.
ANNOUNCER: There are also exciting possibilities about combining the vaccine with other therapies and using it on a more wide spread basis.
RONALD LEVY, MD: We would love to be able to combine an active vaccine with a monoclonal antibody treatment, such as Rituxan or other monoclonal antibodies that are being developed. We'd love to try it in other kinds of B-cell lymphomas and T-cell lymphomas. There's no reason this couldn't also be used with aggressive lymphomas or what we call intermediate-grade lymphomas. There's no reason it couldn't be used after bone-marrow transplantation. There's no reason it couldn't be used as the first treatment, instead of chemotherapy.
ANNOUNCER: The development of this vaccine may have far reaching implications and the trials to test it are the first step in making these customized vaccines a reality for all patients.
DAVID FISHER, MD: We know, with chemotherapy, that people tend to have their disease come back. So why not try something that may turn the tables and keep the disease away longer or perhaps eradicate it and what could be better than a drug that's designed to attack my specific lymphoma, my own protein on the surface of the cell? Hopefully, this will pay -- will pay off in the future. Time will tell.
ANNOUNCER: For more information on the Clinical Trials of Idiotype Vaccine in Non-Hodgkin's Lymphoma, visit the Lymphoma Research Foundation website at www.Lymphoma.org.