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Anyone heard of this at Mayo Clinic? Two Drugs Help Fight Kidney, Breast Cancer

i_love_my_dad
Posts: 20
Joined: Jan 2013

http://www.mayoclinic.org/news2012-jax/7014.html

It said "romidepsin and decitabine, work cooperatively to activate a potent tumor suppressor gene that is silenced in these cancers. Once the gene, secreted frizzled related protein one or sFRP1, went to work after the drugs were used, the laboratory tumor cells stopped growing and died."

Has anyone heard of this before? looks interesting. Hopefully we can get a new weapon soon. 

I don't know which stage it is at. I think they haven't started any clinical trials yet? But given that the two drugs are already FDA approved, will the process be shorter? 

Good luck to everyone! 

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Yes, it's a very promising, novel treatment approach and yes the fact of both being already FDA approved will substantially shorten the approval process.

The limiting time factor will probably be the translational process in moving from in vitro studies to murine studies and thence to trials with human subjects.  With any luck that will happen quickly and will realise your wish "Hopefully we can get a new weapon soon". 

It's definitely a space to keep an eye on.

Eliezer2
Posts: 58
Joined: Aug 2012

Each of the two components is already FDA approved for other problems.  The innovation here is using the two to wake up a dozing gene that can fight the disease.  I share your excitement.  My only qualm is I think we do NOT want to be among the first guinea pigs on whom it is tested before it is approved for treating RCC if we can hang in there with other treatments until that happens.  

 

Probably just my personality but I worry about surprises that could make things worse.  And if Sutent or one of the other meds is working for now to keep you stable, maybe better not mess with new things until they have been proven on others. 

i_love_my_dad
Posts: 20
Joined: Jan 2013

I agree with you that we do not want to be the first triers. But it is always good to have some hope :) I will keep looking for potential new treatments and share with you (Though do not know whether people are interested in..) Good luck to us all!  

BDS's picture
BDS
Posts: 105
Joined: Aug 2012

I_Love_My_Dad - there are many new treatments for RCC currently in Clinical Trials around the world. Below is my compilation of what I believe are the most promising treatments that are on the horizon for RCC. Hopefully, these new drugs/treatments will receive FDA approval within the next 1-3 years. Each drug I mention contains snippets of information that I have copied from the Internet. - BDS      

 

 

Tivozanib (Aveo Pharmaceuticals) is a potent pan-VEGF receptor tyrosine kinase inhibitor. The biological activity of tivozanib seems to outstand that of other VEGF tyrosine kinase inhibitors. In Phase I studies, observed side effects are generally mild, with hypertension being the most common adverse event. In single-agent Phase II and III studies in patients with advanced or metastatic renal cell carcinoma, tivozanib has demonstrated convincing clinical activity.

In a statement, Aveo said that the FDA has accepted the company’s NDA, submitted in September, for tivozanib as a treatment for advanced renal cell carcinoma (RCC), or kidney cancer. The FDA’s review of the candidate is expected to be completed by July 28, 2013, the company said. The NDA includes results of the global Phase 3 trial, TIVO-1, of 517 patients with advanced RCC. The study showed that tivozanib was the first product to demonstrate more than one year of progression-free survival for patients who had never taken medication for the disease before. In a head-to-head comparison, AVEO’s drug candidate bested Nexavar, the current standard of care, made by Onyx Pharmaceuticals.

 

AVEO Oncology  Astellas Pharma Inc. today announced that new clinical data on tivozanib, an investigational agent for the treatment of metastatic renal cell carcinoma (mRCC), will be presented at the 2013 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 14-16 2013 in Orlando, Florida Presenter: Robert Motzer, M.D.   Date & Time: Saturday, February 16, 2013; 6:45-7:55am

WebLink:http://www.aveooncology.com/our-product-candidates/tivozanib/renal-cell-carcinoma/

Search Youtube for Videos:

 

BNC-105P: There is an Australian company called Bionomics that is conducting clinical trials of a new promising drug called BNC105 or BNC105P.  BNC105 is a vascular disrupting agent that shuts down the blood supply to solid tumors.

Web Link: http://www.bionomics.com.au/index.php )

Search Youtube for Videos:

 

BMS-936558/Nivolumab (Bristol-Myers Squibb):  It is proposed that the anti-PD-1 treatments currently being investigated work against the cancer cells by blocking them from binding to and activating PD-1. This helps the body reactivate the immune response and fight back against the cancer.

Web Links: http://www.bmsanti-pd-1drugresearchstudies.com/index.aspx

Search Youtube for Videos:

 

IMA901 vaccine: Completed a European multi-centerphase 2 clinical trial in renal cell carcinoma in Q4 2009. 68 patients with advanced renal cell carcinoma were treated and highly encouraging overall survival rates were observed in the treated patients, significantly improving on the data seen from market-leading drugs in previous studies. Furthermore, IMA901 showed an excellent safety profile. Based on these very encouraging results and on discussions with regulatory bodies in the US (FDA) and Europe (EMA), immatics initiated a pivotal, randomized, controlled phase 3 study that, presenting positive outcomes could soon lead to the market approval of IMA901.

 

Web Links: http://www.immatics.com/index.php

                    http://www.immatics.com/index.php?action=download&id=571

Search Youtube for Videos:

 

TVAX Biomedical is a clinical stage drug development company advancing its novel targeted cell-based immunotherapy for the treatment of cancer.

TVI-Kidney-1 is being evaluated for the treatment of kidney cancer and targets stage IV renal cell carcinoma.As with TVI-Brain-1, this drug candidate is supported by positive Phase 2 clinical data, as well as extensive preclinical and Phase 1 safety studies.  Based on these supportive data, TVAX has been authorized by the United States Food and Drug Administration (FDA) to conduct pivotal Phase 3 trials for TVI-Kidney-1 to support the therapy’s potential FDA approval.  The company has prioritized the TVI-Brain-1 program at this time, but intends to initiate the TVI-Kidney-1 pivotal Phase 3 trial in the near future.

Web Links: http://www.tvaxbiomedical.com/index.shtml

 

Argos Therapeutics

AGS-003 is an investigational, fully personalized, cancer immunotherapy being evaluated in a phase 3 clinical study in combination with targeted drug therapy for the treatment of metastatic renal cell carcinoma (mRCC).

To make AGS-003, a small tumor sample is obtained during the initial, standard surgery (nephrectomy). Following recovery from surgery, a blood donation procedure (leukapheresis) is performed to collect a certain type of blood cell which is required to make powerful dendritic cells. Once these elements are combined, up to 5 years of treatment is made for each patient.

Where AGS-003 Fits:

Adding AGS-003 to targeted drug therapy may represent an important advancement in the treatment of advanced kidney cancer. In a previous clinical trial, AGS-003 was safely added to a commonly used targeted therapy and appeared to trigger an immune response which helped patients fight their cancer.

Web Link: http://adaptkidneycancer.com/

 

AGS-16C3F

Not Sure Who Makes this Drug: AGS-16C3F is an antibody-drug conjugate. It is composed of an antibody which binds to a specific receptor on cancer cells. Once there, a chemotherapy drug that is bound to the antibody can kill the cancer cell. AGS-16C3F is given intravenously (by vein).

Weblink: http://www.mskcc.org/cancer-care/trial/12-162

 

 

Interesting Articles:

 

Rice-Cell Cocktail Tough on Cancer Cells, Nice to Normal Cells

Weblink: http://www.newswise.com/articles/rice-cell-cocktail-tough-on-cancer-cells-nice-to-normal-cells

 

Marijuana and Cancer: Scientists Find Cannabis Compound Stops Metastasis In Aggressive Cancers

 

Weblink:  http://www.huffingtonpost.com/2012/09/19/marijuana-and-cancer_n_1898208.html?icid=maing-grid10%7Chtmlws-main-bb%7Cdl1%7Csec3_lnk1%26pLid%3D207936

 

GSRon's picture
GSRon
Posts: 1306
Joined: Jan 2013

Wonderful information...  I do have an idea...  I think it would be a good thing to have two separate sub forums, so to speak, one that lists all the current FDS approved treatments, and one for the treatments that are still in the study mode..  Both with no other commentary, just pure information...   That way it would be easy for us all to use as a reference guide, so to speak...  Just me thinking out loud...

Ron

i_love_my_dad
Posts: 20
Joined: Jan 2013

Or if it is hard to have sub forums, is there a way to create stiky post? We can just compile useful information from the discussions to that post and update it periodically. 

i_love_my_dad
Posts: 20
Joined: Jan 2013

That's such wonderful information! And exactly what I've been looking for! Thanks so much, BDS!!! I burst into tears when read your post. I will share this with my  Dad and I am sure he will get more courage to fight with the desease! 

I am a full time student so I am slow in searching for new information. But I am doing it everyday and will try my best to share everything valuable with you all! Love you! 

 

i_love_my_dad
Posts: 20
Joined: Jan 2013

I think this drug is worth adding to your list. Here is the link

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=95382

The interesting part is that most patients were heavily treated (Sutent or sth) before entering the trial. The data is quite encouraging. I first saw the name of the drug from Chris Battle's blog. 

BDS's picture
BDS
Posts: 105
Joined: Aug 2012

Cabozantinib (Exelixis Inc.) is an inhibitor of both VEGFR2 and c-Met, both of which promote angiogenesis. 25 patients were evaluated, all of whom had prior therapies for kidney cancer, mostly VEGF or mTOR inhibitors. This was an experienced group as close to half of the patients had three or more prior therapies. For example, 14 of the 25 had previously taken sunitnib (Sutent). The dosage was 140 mg/daily, which was previously determined to be the maximum tolerated dose (MTD). Other studies have used 40 mg to 140 mg, with the lower dose showing efficacy in prostate cancer. Exelixis, the biotech company that developed the drug, will consider dose reduction in the future for RCC. 

 

Response


The progression-free survival (pfs) for the 25 patients was 14.7 months. With respect to tumor shrinkage, 21 patients were evaluated, and, based on RECIST criteria, of those, 7 had a partial response (>30% shrinkage), 13 had stable disease, and one had progression. In total, 19 of the 21 evaluated patients had some shrinkage, although one had progressive disease due to new lesions.  

 

Based on prostate trial data, cabozantinib has demonstrated significant efficacy in reducing or eliminating bone lesions. There were four rcc patients with bone lesions at baseline, two with pain. The pain resolved for both and one has continued to be pain-free for 73 weeks. One patient did develop new bone lesions. According to Exelixis, in addition to cabozantinib’s effect on osteoblasts and osteoclasts, an anti-tumor effect was also noticed in the bone lesions. It will be interesting to see further elucidation of this since, as compared with Zometa, which is an agent that has been used successfully to treat bone metastases, it is still unclear if there is an anti-tumor effect. 

 

What stands out in this trial is the response rate, specifically the pfs of 14.7 months and some tumor shrinkage in 19 of the 21 evaluated patients for a patient mix that was heavily pre-treated. For example, of the 7 patients who showed partial tumor response (> 30% shrinkage), 4 of them had four or more prior treatments. The best pfs in current therapies is about a year, and this is mostly for treatment-naïve patients. The axitinib-sorafenib second-line trial (with one prior therapy) yielded a pfs of 6.7 months and 4.7 months for axitinib and sorafenib, respectively. Additionally, the patients on this trial were all in the intermediate and poor risk categories. Most trials have patients who have good and intermediate risk for recurrence. Cabozantinib also demonstrated efficacy against bone lesions, following its similar history with prostate cancer. The drug also seems to be well-tolerated without the significant hypertension and possibly concomitant heart issues found in other tyrosine kinase inhibitors.  

Although the numbers are small, there doesn’t seem to be a relationship between number of prior therapies and response to cabozantinib. In other words, it doesn’t matter how many priors you’ve had, you still have a possibility of tumor response to cabozantinib.

 

Weblink: http://www.exelixis.com/

 

Note – (I could be wrong on this But…) Only a Phase 1 trial has been completed with Cabozantinib for RCC.   From what I can currently determine the company (Exelixis) is not vigorously pursuing a Phase 2 clinical trial.  I cannot find any mention of it on ClinicalTrials.gov only on Exelixis website where it is in a status of “Not Yet Recruiting”.  - BDS

i_love_my_dad
Posts: 20
Joined: Jan 2013

I remember Chris Battle mentioned there was just one clinical trial for RCC which require bone mets. The good news is we can get the drug. The bad news is it is very expensive and cannot be covered by insurance now. Hopefully more clinical trials will be conducted. 

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

If you want to learn more about cabo try Matt Ivy on  KIDNEY_ONC. 

Because it's been around for a while it's worth looking on sites for other cancers, for instance an interesting bit on the CSN uterine cancer forum back in 2011 by a very interesting poster who has researched like just about nobody else I've ever heard of - see his Resources entry

His post about cabo is at:

http://csn.cancer.org/node/229033

[I just give this as an example of how it's worthwhile spreading nets wide when investigating a drug already in use for other illnesses.]

i_love_my_dad
Posts: 20
Joined: Jan 2013

I was looking at IMA901 and MDX 1106. I think they are both at phase III. If everything goes smoothly, how long will a phase III study take? 

BDS's picture
BDS
Posts: 105
Joined: Aug 2012

According to my oncologist BMS-936558/Nivolumab is a three year clinical trail. They just started the phase 3 clinical trial for IMA901 I am assuming the same. If your father can get into any of these clinical trials I would suggest he do so. Since right now I am responding well on Votrient I am not considered eligible for a clinical trial. - BDS  

i_love_my_dad
Posts: 20
Joined: Jan 2013

Thanks BDS. You are so nice. The fact is we are not able to take part in any clinical trials: my father is not in the US and I am a poor foreign PhD student in the US who just got the bad news from my parents. I want to drop out but it is my parents' dream to see their only daughter finishing her PhD, so I have to insist, though I almost cry everyday. Sometimes I really want to die since life is too tough, I cannot do anything but searching for new info for my father. I made some mistake again in my work, and I guess my teacher is very disappointed at me. I really admire that you have so many ways to deal with the desease-at least there are many ways to try. We even do not have all the FDA approved targeted therapies in my country. I just hope God can give us more time. I would like to exchange five years for my father with everything of mine, including my life. Sorry for being so emotional. Need to adjust myself and search for new hope for my father. I have to be strong. Good luck to everyone.

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