Vacinas e "clinical trials" para câncer de próstata avançado
Atendendo a um pedido de parentes de paciente muito avançado fiz uma busca sobre os clinical trials
com vacinas. Os resultados seguem abaixo.
- Um procedimento que muitos médicos americanos recomendam a seus pacientes com câncer muito avançado e que já exauriram as possibilidades disponíveis com certa facilidade, é que busquem clinical trials. Neles, um novo tratamento ou uma nova combinação de tratamentos já disponíveis é testada. Os pacientes são, em certo sentido, cobaias e aceitam esse papel. Não só aceitam, mas procuram, buscam. Menciono uns clinical trials abaixo.
ul> Uma das pesquisas se refere à GVAX, com breve descrição do produto abaixo e da abertura para pacientes. Infelizmente, terá que fazer a pesquisa na internet acompanhado(a) por alguém que leia bem em Inglês. Clicando em Patient Information poderá obter informações úteis.
A URL do site: http://www.cellgenesys.com/clinical-prostate-cancer.shtml
Our GVAX immunotherapy for prostate cancer is a non patient-specific product comprised of two genetically-modified prostate cancer cell lines. We intend to develop and manufacture this immunotherapy as an "off-the-shelf" pharmaceutical for use after hormonal therapy for advanced-stage prostate cancer. Prostate cancer is the second leading cause of cancer death in men in the United States, with approximately 30,000 men dying each year from the disease. When a man is diagnosed with early-stage prostate cancer, he is treated with either a prostatectomy (surgical removal of the prostate) or radiation therapy. If the patient relapses, he is treated with hormone therapy to suppress testosterone in order to reduce the growth of the tumor. When the hormone therapy fails, the patient may or may not be treated with chemotherapy depending upon whether the disease has spread, or metastasized, to other parts of the body. We have designed our Phase 3 clinical trials to evaluate whether GVAX immunotherapy for prostate cancer can benefit patients who have ceased responding to (become refractory to) hormone therapy and have metastatic disease.
We have completed five Phase 1 and Phase 2 clinical trials of our GVAX immunotherapy for prostate cancer in approximately 200 patients with various stages of recurrent prostate cancer, and the immunotherapy has had a favorable safety profile in each trial. These clinical trials include two Phase 2 clinical trials in hormone-refractory prostate cancer patients with radiologic evidence of metastatic disease ("metastatic HRPC"), which is the target population for our current Phase 3 trials. These trials were designed to evaluate the safety and efficacy of the immunotherapy, as well as dosing regimens for Phase 3 clinical trials.
In September 2002, we reported final data from our first Phase 2 multicenter clinical trial of the prostate cancer immunotherapy in metastatic HRPC. Thirty-four patients were entered in the trial and were assigned to receive either low dose (24 patients) or high dose (10 patients) of the immunotherapy as their only cancer therapy for up to a six-month period. The combined median survival for both dose groups was 26.2 months. These results compare favorably to the previously published median survival for Taxotere® (docetaxel) chemotherapy in combination with prednisone. This Taxotere regimen is approved by the FDA for the treatment of patients with this stage of prostate cancer and is now the currently approved standard of care. Our ongoing Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate câncer.
Updated data from the second Phase 2 clinical trial were presented at the February 2006 American Society of Clinical Oncology (ASCO) Prostate Cancer Symposium. The fully enrolled study includes 80 HRPC patients with evidence of metastasis (spreading) to the bone and other sites. Patients enrolled in this Phase 2 clinical trial, which evaluated escalating doses of the cancer immunotherapy, were monitored for safety and for evidence of clinical activity induced by the immunotherapy. The results to date for the 22 patients who received a dose comparable to that being employed in our ongoing Phase 3 trials indicate that the median survival has not yet been reached for these 22 patients, and the estimated Kaplan-Meier median survival is expected to meet or exceed 29.1 months based on the patients still in follow-up. Four patients have withdrawn consent to further follow-up and thus were censored in the analysis.
Data from a Phase 1 clinical trial of GVAX immunotherapy for prostate cancer, administered in combination with ipilimumab (MDX-010), a fully human antibody to CTLA-4 being jointly developed by Medarex and Bristol-Myers Squibb were presented at the February 2007 ASCO Prostate Cancer Symposium. Twelve patients with advanced prostate cancer have completed dosing to date, including six patients who received the combination therapy at the therapeutic doses currently being evaluated in both GVAX and ipilimumab Phase 3 clinical trials. Antitumor activity was observed in five of these six patients, including greater than 50% reductions in prostate-specific antigen (PSA) levels that were maintained in four of these patients for at least six months with two patients having greater than 95% reductions. Moreover, clinical evidence of antitumor activity was observed in three of the five PSA responders. All five patients with PSA declines experienced immune-mediated endocrine deficiencies which were similar in type to those previously reported for ipilimumab and were successfully treated with standard hormone replacement therapy. This dose-escalation combination trial is currently expected to enroll a total of approximately 25 to 30 patients.
We are conducting two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer in metastatic HRPC. The first Phase 3 clinical trial (VITAL-1) commenced in July 2004 and compares GVAX immunotherapy for prostate cancer to Taxotere chemotherapy administered with prednisone with respect to survival benefit in metastatic HRPC patients who are asymptomatic with respect to cancer-related pain. The VITAL-1 trial is designed to demonstrate superior survival in the patients receiving GVAX cancer immunotherapy compared to patients receiving Taxotere plus prednisone therapy and is expected to enroll approximately 600 patients. The second Phase 3 clinical trial, referred to as the VITAL-2 trial, commenced in June 2005 and compares GVAX immunotherapy for prostate cancer plus Taxotere chemotherapy to Taxotere chemotherapy plus prednisone with respect to survival benefit in metastatic HRPC patients with cancer-related pain. We expect to enroll approximately 600 patients in the VITAL-2 trial. VITAL-1 and VITAL-2 are both being conducted in the United States, Canada and Europe.
In May 2006 the FDA granted Fast Track designation for GVAX immunotherapy for prostate cancer. Fast track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate development and expedite the review of Biologics License Applications ("BLAs"). Fast track designation is reserved for products that demonstrate the potential to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for that condition.(The data referenced in the preceding paragraphs represent the most recently announced data pertaining to this program.)
Please visit the Patient Information section of this site to learn more about clinical trials currently open for enrollment.
ü Na Austrália há outro clinical trial, muito menor e menos avançado, anunciado.
Reproduzo o que captei numa fonte local:A NEW vaccine developed by Brisbane scientists to combat prostate cancer appears safe in the first five patients studied in a phase-one trial.
Mater Medical Research Institute director Professor Derek Hart, who led the team which took six years to develop the vaccine, yesterday injected the third of three doses into Warwick carpenter Wayne Brown, 61, at the institute.
Mr Brown, the fifth patient to try the vaccine, was diagnosed with prostate cancer several years ago.
"I had hormone treatment, pills and injections for a few years but the PSA (prostate-specific antigen) level started going up again so I'm happy to give the vaccine a go," Mr Brown said.
Another seven patients will be vaccinated in coming months.
Mr Brown's treatment coincided with a visit to the institute by State Development Minister John Mickel, who announced a $500,000 funding boost for the program from the Smart State Health and Medical Research Fund to help cover day-to-day operational costs.
He said the fund was designed to boost the national competitive research strength of Queensland's independent medical research institutes and attract further investment.
"The kind of research conducted by the Mater Medical Research Institute is of enormous significance - and the work being done with the prostate cancer clinical trial will benefit many men," Mr Mickel said.
"The institute is a world-class facility, and its research programs have attracted some of the best scientists in the world."
Professor Hart said the funding was most welcome, as the total cost of the trial was about $5 million and had been made possible through state and federal funding and $1 million from Brisbane businessman Bill Siganto.
Professor Hart said each injection for the program cost $20,000, but that would be reduced to $15,000 when a refined and improved version began trials later this year.
Professor Hart hopes phase-two trials, to begin in two to three years, will enable men with less advanced prostate cancers, such as those operated on or having received radiotherapy, to access the program.
He said it would be at least five years before the vaccine was generally available.
The vaccine works by retraining dendritic blood cells to seek out and attack the cancer in a way similar to an attack on a cold or flu. The vaccine involves patients entering hospital to have blood taken for the vaccine, which is administered the next day. For more information on the research work call 3840 2555.
- Outra tentativa, mais badalada, se refere ao Provenge. É vacina que vem dando bons resultados, mas que foi inicialmente rejeitada pela FDA. Entendo que pode ser obtida na Europa (e, talvez, no Canadá). Detalhes abaixo:
WASHINGTON - Federal health advisers have endorsed an experimental vaccine to treat advanced prostate cancer as safe and effective.
The Food and Drug Administration advisers voted unanimously Thursday to say Provenge is safe. They then voted 13-4 to say there is substantial evidence that it works in treating advanced prostate cancer that no longer responds to hormone treatment.
The FDA isn't required to follow the advice of its advisory committees, but it usually does. A final FDA decision on whether to approve Provenge, also called sipuleucel-T, is expected May 15. The vaccine is made by Seattle-based Dendreon Corp.
If approved, Provenge would become the third cancer vaccine but the first that is therapeutic. FDA-approved vaccines against liver and cervical cancer are both preventive.
Neither of two studies Dendreon submitted to the FDA in support of its application achieved their primary goal in showing Provenge delayed the progress of the disease, according to the agency.However, the results of the first study suggested the vaccine could extend the lives of patients by 4.5 months compared to those given only dummy treatment.
The only other prostate cancer drug shown to prolong the lives of patients is Taxotere, also called docetaxel. A larger, ongoing study of Provenge is looking specifically at whether it increases longevity of prostate cancer patients. If ultimately approved, Provenge would become the first of a new class of therapies designed to stimulate a patient's own immune system against cancer, according to Dendreon.
Prostate cancer is the most common cancer in American men, other than skin cancer. The American Cancer Society estimates there will be about 220,000 new cases this year, and about 27,000 deaths.
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