Rak-Prostaty ~ Prostate-Cancer

Szczepionka przeciwko rakowi prostaty badana będzie także w Polsce
http://goo.gl/m6Oz8R

złowione dzisiaj z Onetu
http://www.medonet.pl/zdrowie-na-co-dzien,artykul,1689216,1,szczepionka-na-raka-prostaty-ktora-opracowala-polka-badana-jest-na-chorych,index.html

drGoogle pisze:Szczepionka przeciwko rakowi prostaty badana będzie także w Polsce
http://goo.gl/m6Oz8R

Jeśli ktoś był łaskawy przeczytać informację spod ww. linku, zapewne dowiedział się, że sprawą wprowadzania tej szczepionki w Polsce zajmuje się dr Iwona Skoneczna. Do Pani dr wysłałem e-maila z zapytaniem o warunki, jakie trzeba spełnić, żeby być przyjętym na to badanie. Otrzymałem odpowiedź, oto ona:

"Panie Władysławie,

Zasadniczo do tego badania kwalifikują się chorzy z potwierdzona chorobą przerzutową w kościach ( ale niestety nie w wątrobie i płucach) oraz po niepowodzeniu leczenia bikalutamidem ( np. wzrost w trakcie i po odstawieniu bikaluutamidu) ale bez dolegliwości i oczywiście jeszcze przed chth.

W Warszawie otwartych jest 5 ośrodków min. COI dr Sikora-Kupis, szpital CSK MSW Wołoska dr Nurzyński, MAGODENT dr Szarosiek i mój ośrodek, który powoli się otwiera ale przez najbliższy miesiąc jeszcze nie mam możliwości przyjmowania nowych chorych.

Pzdr,

IS "

Szczgoly dotyczace badania klinicznego 1/2 fazy szczepionka opracowanej przez niemiecka firme CureVac GmbH

A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-Derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients With Metastatic Castrate-refractory Prostate Cancerer

The purpose of this study is to determine whether the new RNActive-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.
[Celem badania jest sprawdzenie czy szczepiona CV9104 przedluza przezycie u pacjentow z asyptomatycznym lub minimalnie symptomatycznym przerzutowym, opornym na kastracje raku prostaty.

Randomized
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:Treatment

Primary Outcome Measures:
Phase I (Safety Lead-In): Occurence of dose-limiting toxicity (DLT) during the first 4 weeks of treatment (after administration of 3 vaccinations and after a 1 week observation period [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]

Safety Lead in Portion: Patients will receive CV9104 at a starting dose of 1920 µg in weeks 1, 2 and 3. Safety lead-in patients will be observed for DLTs until 1 week after Vaccination 3 (week 4).
In case no DLTs will be observed vaccinations will continue in weeks 5, 7, 9, 12, 15, 18 and 24, then every 6 weeks for up to 12 months after the first vaccination and then every 3 months thereafter until one of the criteria for study treatment discontinuation is met

Phase II (Randomised Portion): Overall Survival from time of randomisation- up to 3.5-4 years. [ Time Frame: Overall survival will be assessed during the lifetime of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Detailed Description:
The study is the first clinical study with the new prostate cancer vaccine CV9104. This vaccine is composed of 6 RNActive-based compounds, each encoding for an antigen that is overexpressed in prostate cancer compared to healthy tissues. RNActive-based vaccines are a novel class of vaccines based on messenger RNA.

The study is a double-blind randomized placebo-controlled phase I/II trial in men with asymptomatic- minimally symptomatic metastatic castrate-refractory prostate cancer.

The phase 1 (safety lead- in) part of the trial has the primary objective to assess the safety of CV9104 and to determine the dose for the randomized phase II part.

The primary objective of the phase II part is to compare overall survival in patients treated with CV9104 compared to patients treated with placebo.

Key Inclusion Criteria:
1. Male, age ≥18 years

2. Histologically confirmed castrate refractory metastatic adenocarcinoma of the prostate with progressive disease after surgical castration or during androgen suppression therapy including a GNRH agonist or antagonist and after at least 1 additional anti-hormonal manipulation; and serum testosterone level of < 50 ng/dL or < 1.7 nmol/L

Progression will be confirmed either
* radiologically or
* by 2 consecutive rises of PSA, measured at least 1 week apart, resulting at least in a 50% increase over the nadir and a PSA > 2 ng/mL.

* An antiandrogen withdrawal response must have been excluded after discontinuation of antiandrogen therapy for at least 6 weeks.

3. Metastatic disease confirmed by imaging
4. ECOG performance status 0 or 1

Key Exclusion Criteria:
1. Previous immunotherapy for PCA (e.g. sipuleucel-T [Provenge®], experimental cancer vaccines or ipilimumab [Yervoy®]).

2. Treatment with any investigational anticancer agents within 4 weeks prior to first dose of study drug

3. Systemic treatment with immunosuppressive agents

4. Active skin disease (atopic eczema, psoriasis) in the areas for vaccine injection (upper arms or thighs) preventing the administration of i.d. injections into areas of healthy skin.

5. History of or current autoimmune disorders

6. Primary or secondary immune deficiency.

7. Seropositive for human immunodeficiency virus, hepatitis B virus (except after hepatitis B vaccination) or hepatitis C virus infection.

8. Symptomatic congestive heart failure (New York Heart Association 3 or 4), unstable angina pectoris or myocardial infarction, significant cardiac arrhythmia, history of stroke or transient ischemic attack, all within 6 months prior to enrolment or severe hypertension according to WHO criteria or uncontrolled hypertension at the time of enrolment (systolic blood pressure ≥ 180 mm Hg)´

9. Previous chemotherapy for metastatic PCA.

10. Previous anti-hormonal treatment with abiraterone or any other investigational anti-hormonal treatment.

11. Cancer-related pain requiring opioid narcotics within 28 days before enrolment or an average pain score of > 3 on a visual analogue scale.

12. Presence of visceral metastases.

13. History of other malignancies other than PCA over the last 5 years (except basal cell carcinoma of the skin).

http://clinicaltrials.gov/show/NCT01817738

Lista polskich osrodkow prowadzacych aktualnie badz potencjalnie badanie kliniczne NCT01817738

Szpital Uniwersytecki im. Dr. Jurasza w Bydgoszczy, Klinika Urologii Ogólnej, Onkologicznej i Dziecięcej Recruiting
Bydgoszcz, Poland

Oddzial Kliniczny Urologii, SP ZOZ Szpital, Szpital Uniwersytecki w Krakowie Not yet recruiting
Krakow, Poland

Medica Pro Familia Krakow Recruiting
Krakow, Poland

CRH Zagiel Med. Sp. z o.o., Sp. j., ul. Zana 32a, 20-601 Lublin Recruiting
Lublin, Poland

Centrum Urologiczne Sp. z o.o. Recruiting
Mysłowice, Poland

Centralny Szpital Kliniczny MSWiA, Klinika Onkologii I Hematologii Recruiting
Warsaw, Poland

Instytut M. Curie-Skłodowskiej Not yet recruiting
Warsaw, Poland

NZOZ Magodent, Centrum Medyczne Ostrobramska, Oncologii Klinicznej i Chemíoterapii Recruiting
Warsaw, Poland

Szpital Uniwersytecki, Katedra i Klinika Urologii i Onkologii Urologicznej Recruiting
Wroclaw, Poland

Profesorskie Centrum Medyczne OPTIMUM Wrocław Recruiting
Wroclaw, Poland

Czy wiadomo co się teraz z tą szczepionką dzieje? Ruszyło to w ogóle i na jakim etapie są badania?

donker pisze:Czy wiadomo co się teraz z tą szczepionką dzieje? Ruszyło to w ogóle i na jakim etapie są badania?

Donker,
Wystarczy kliknac na link w moim poscie z 2013 roku by miec odpowiedz na powyzsze pytanie:

Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
CureVac AG
Information provided by (Responsible Party):
CureVac AG

Badanie trwa, ale nie rekrutuje sie (juz) pacjentow.

Domyśliłam się, że nie rekrutują. Szukałam za to na własną rękę tej informacji w google ale z mizernym skutkiem. Dziękuję Zosiu

donker pisze:Domyśliłam się, że nie rekrutują. Szukałam za to na własną rękę tej informacji w google ale z mizernym skutkiem. Dziękuję Zosiu

Zawsze szukaj na amerykanskiej rzadowej stronie

http://www.clinicaltrials.gov

Wszystkie powazne proby kliniczne sa tam publikowane i (na ogol) aktualizowane przez organizatora/sponsora.

Znalezienie ponizszej listy zabralo mi 5" (Google i fraza "clinical trials prostate cancer")

Clinical Trials Search Results - National Cancer Institute
http://www.cancer.gov/about-cancer/trea ... id=4411473

Teraz musisz odcedzic od reszty:
a/ trials prowadzone w PL
b/ trials, ktore prowadza nabor - Recruiting

pzdr
zosia

Dziękuję jeszcze raz i będę o tych wskazówkach pamiętać.
Pozdrawiam i życzę miłych i spokojnych Świąt.
donker

Dr. Tomasz Beer, z-ca dyr. w Oregon Health & Science

Dr Beer jest jedym z sześciu głównych naukowców biorących udział w zespole badań ds. leczenia zaawansowanego raka gruczołu kroczowego:

Prostatepedia spoke with him recently about immunotherapy for prostate cancer.

What is immunotherapy and how is it used in prostate cancer treatment?

Dr. Beer:
Our immune systems are capable of controlling, or maybe even eliminating cancer. Immunotherapy provides some sort of treatment or intervention that helps engage the immune system in that task. There are a number of different ways to do that. While we’ve been working on immunotherapy for several decades, it’s still in its infancy. We don’t have a full and complete understanding of how the immune system works and how to manipulate it to our advantage.

We know enough now that cancer treatments that rely on the immune system continue to become a reality for patients and to make a difference.
We’re in that transition period between preliminary and developing opportunities to deliver reliable treatments.

How does it work?

In an antigen-specific approach, we develop a vaccine or some other way to activate the immune system against a particular antigen (a protein made by a cancer cell) that is unique or predominant to the cancer.

Another approach is to activate the immune system more generally, and by doing that, hope that the immune system distinguishes between our own antigens and the cancer’s.

These approaches are therapeutic. These are not the sorts of vaccines that we think of in terms of the prevention of infectious diseases, where we vaccinate ourselves when we’re healthy to build up immunity before an infection. Right now, immunotherapy means treatment for an established cancer.

So then these vaccines don’t prevent cancer: this is a type of treatment.

Dr. Beer:
Yes. For example, the vaccine against HPV infections is a conventional antiviral vaccine for a viral infection, and because the virus leads to cervical cancer, it’s also a cancer prevention strategy. That is a different way to use the immune system to fight cancer. Immunotherapy is therapeutic cancer vaccination.

Why are some forms of immunotherapy more effective for different kinds of cancer? What is it about prostate cancer that makes it more susceptible to that kind of approach?

Dr. Beer:
First, we don’t have a full understanding of these distinctions. Second, just because there are treatments for one disease and not another doesn’t necessarily mean that prostate cancer is more susceptible.

Dendreon, the company that developed the vaccine for prostate cancer, focused on prostate cancer and did not have the resources or bandwidth to try the same thing for other cancers extensively. It’s sort of an accident of history in the case of Provenge (sipuleucel-T).
That particular vaccine targeted a prostate cancer-specific antigen called PAP, so it wouldn’t have worked in its normal form against other cancers.
One could take a similar approach with an antigen that was specific to other tumor types, but it just hasn’t happened yet.

With immune checkpoint inhibitors—the most contemporary form of therapy—we think that some cancers are more susceptible because they have more abnormal antigens. The cancers with higher mutational burden seem to respond better to these agents and it’s probably because they’re more different than normal cancers with pure mutations.

There are also other factors. For instance, melanoma or kidney cancers have traditionally been thought of as more susceptible to immune interventions because there are rare patients whose native immune systems were successful against them. But we don’t know if one cancer is more susceptible to immune therapy than another or for what reason. We’re still learning about that.

https://www.prostatepedia.net/blogs/pro ... fecf14b747

Rak-Prostaty ~ Prostate-Cancer

szczepionka na raka prostaty

IMMUNOTERAPIA

szczepionka na raka prostaty

Re: szczepionka na raka prostaty

Re: szczepionka na raka prostaty

Re: szczepionka na raka prostaty

Re: szczepionka na raka prostaty

Re: Szczepionka na raka prostaty

Immunoterapia