HonCode

Go Back   HER2 Support Group Forums > Clinical Trials
Register Gallery FAQ Members List Calendar Today's Posts

Reply
 
Thread Tools Display Modes
Old 08-14-2008, 05:59 PM   #1
gdpawel
Senior Member
 
gdpawel's Avatar
 
Join Date: Aug 2006
Location: Pennsylvania
Posts: 1,080
Individualized Online Clinical Trial Protocol Version 1.0

The traditional meaning of Health 2.0, according to Jane Sarasohn-Kahn's "Wisdom of Patients" has been the use of social software and light-weight tools to promote collaboration between patients, their caregivers, medical professionals and other stakeholders in health.

http://www.chcf.org/topics/chronicdi...?itemID=133631

An example of this in cancer medicine is Individualized Online Clinical Trial Protocol Version 1.0 by the Weisenthal Cancer Group, a Phase II evaluation of individualized cancer treatment with traditional cytotoxic chemotherapy, targeted anti-kinase drugs and anti-angiogenic agents.

With most clinical trials, investigators never give out information as to how people are doing. Most trials are failures with respect to actually improving things. The world doesn't find out what happen until after a hundred or 500 or 2,000 patients are treated and then only 24 hours before the New England Journal of Medicine publication date.

Individualized Online Clinical Trial Protocol Version 1.0 is a totally transparent clinical trial. Every patient who decides to enter a study should know what happened to previous patients. Patients are treated in real time, on the Internet, with the whole world watching to see how they do. It includes weekly progress reports, and if individual patients want, their own blogs as to how they are doing.

Stages have been implemented for a rather innovative clinical trial with cell culture assays, "real time" on the Internet. The purpose of the study is to show that cell culture assay technologies for "targeted" agents really do work. The short-term future of cancer therapeutics is combinations of "targeted" agents.

http://weisenthalcancer.com:80/Study%20Pages/TrialHome.htm

They are not "marketing" the test beyond the confines of a clinical trial, which will be the most transparent clinical trial in the history of oncology, as all results are going to be reported, in real time, on a week by week, patient by patient basis, on the website.

Call or e-mail Weisenthal Cancer Group and ask to speak with Connie Rueff, the study coordinator. She will answer any questions you may have and will help you to determine if you are a candidate for entry. (714) 596-2100 or connie@weisenthalcancer.com

About the AngioRx Assay in breast cancer:

ER and PR tests in breast cancer, which detect only VEGF expression, or even overexpression, are valuable not because they measure expression of estrogen and progesterone but rather because they detect (and supposedly measure) the ER and PR receptors in the nucleus. The presence of positive IHC staining of such receptors in at least 10% of nuclei implies that the tumor is hormonally dependent and that, therefore, depriving the cells of the hormone will kill them or retards their growth.

Unlike a test for the presence of receptors to a specific antigen, which only "implies" dependence upon that antigen, an AngioRx assay is functional in that it actually assesses the direct or indirect effect of the drug upon the cell, whether it is a tumor cell or an endothelial cell. VEGF just happens to be one molecule which has been implicated in the process but there may be more.

If it were the only protein involved, then one would expect that VEGF expression would correlate with Avastin activity 100% of the time but it actually does so only about 20% of the time. The AngioRx assay doesn't just focus on VEGF or any one protein or mechanism. Whether it's VEGF alone (unlikely) or in combination with other proteins and other mechanical factors, the assay works by assessing the net effect of all those factors.
gdpawel is offline   Reply With Quote
Old 08-16-2008, 07:37 PM   #2
Jackie07
Senior Member
 
Jackie07's Avatar
 
Join Date: Jan 2008
Location: "Love never fails."
Posts: 5,808
A new form of marketing stragegy? The website states that:

"This is a clinical trial in which the patient will pay for some or all aspects of his or her treatment, which could include surgeries, laboratory tests, expensive anti-cancer drugs, travel (if required), and costs of medical care associated with the treatments. These costs could exceed $100,000. We wish for the patient to be advised that the general topic of patient-sponsored clinical trials has been debated by respected investigators from both sides of the issue and remains controversial."

Please... Don't add more agony to my misery...
__________________
Jackie07
http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2

NICU 4.4 LB
Erythema Nodosum 85
Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d
3 Infertility tmts 99 > 3 u. fibroids > Pills
CN 3 GKRS 52301
IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen
Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET
6 TCH Cellulitis - Lymphedema - compression sleeve & glove
H w x 4 MUGA 51 D, J 49 M
Diastasis recti
Tamoxifen B. scan
Irrtbl bowel 1'09
Colonoscopy 313
BRCA1 V1247I
hptc hemangioma
Vertigo
GI - > yogurt
hysterectomy/oophorectomy 011410
Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk
DEXA 1/13
1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer.
3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer.
Start Vitamin D3 and Calcium supplement (600mg x2)
10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016
7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence.
7-10-2019 CT to check lung nodule.
1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule.
"I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa

Advocacy is a passion .. not a pastime - Joe
Jackie07 is offline   Reply With Quote
Old 08-16-2008, 07:49 PM   #3
Jackie07
Senior Member
 
Jackie07's Avatar
 
Join Date: Jan 2008
Location: "Love never fails."
Posts: 5,808
About Clinical trials

"Limitations and pitfalls of clinical studies in oncology"
[Article in German]
Onkologie. 2008;31 Suppl 2:67-71. Epub 2008 Apr 18

Cerny T.
Fachbereich Onkologie/Hämatologie, Departement Innere Medizin, Kantonsspital St. Gallen, Schweiz. thomas.cerny@kssg.ch

Nowadays results of clinical studies in oncology are often first found and commented in the news media because of their high relevance to the pharmaceutical market. The limits and pitfalls of clinical studies are manifold and not always appreciated even by specialists as well as journalists and politicians. The planning of a study is a most crucial phase, and most deficits are due to inappropriate design and conduct of a study. Adequate and skilful interpretation of a study is often hampered by many known but mostly overlooked variable pitfalls. Today there is an overrepresentation of pharmaceutically sponsored studies and a painful lack of well-designed academic studies with really meaningful endpoints for patient care. This paper touches several important aspects of today's shortcomings of clinical studies in oncology and highlights the importance of strengthening the academic clinical research. Evidence-based medicine needs to be more clinically relevant, and therefore we need well-designed, and critically interpreted studies in the future. Copyright 2008 S. Karger AG, Basel.
__________________
Jackie07
http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2

NICU 4.4 LB
Erythema Nodosum 85
Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d
3 Infertility tmts 99 > 3 u. fibroids > Pills
CN 3 GKRS 52301
IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen
Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET
6 TCH Cellulitis - Lymphedema - compression sleeve & glove
H w x 4 MUGA 51 D, J 49 M
Diastasis recti
Tamoxifen B. scan
Irrtbl bowel 1'09
Colonoscopy 313
BRCA1 V1247I
hptc hemangioma
Vertigo
GI - > yogurt
hysterectomy/oophorectomy 011410
Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk
DEXA 1/13
1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer.
3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer.
Start Vitamin D3 and Calcium supplement (600mg x2)
10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016
7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence.
7-10-2019 CT to check lung nodule.
1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule.
"I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa

Advocacy is a passion .. not a pastime - Joe

Last edited by Jackie07; 08-16-2008 at 07:54 PM..
Jackie07 is offline   Reply With Quote
Old 08-16-2008, 09:31 PM   #4
gdpawel
Senior Member
 
gdpawel's Avatar
 
Join Date: Aug 2006
Location: Pennsylvania
Posts: 1,080
"Real World" Study

The very new test, called the Microvessel Vascular (MVV) assay for detecting drug-mediated death of tumor infiltrating endothelial cells is not being marketed beyond the confines of a clinical trial, which will be the most transparent clinical trial in the history of oncology, as all results are going to be reported, in real time, on a week by week, patient by patient basis.

The most immediate application of the MVV assay focuses upon cancer and specifically upon a much-heraled new class of agents called angiogenesis-inhibiting drugs, which work by attacking tumor vasculature and thereby starving cancer cells. One problem with these drugs, in addition to their high cost, is determining in advance who will benefit from them. The other problem is learning how to make the drugs more effective by using them in combination. The new MVV test could help on both fronts.

The test works by measuring drug effects upon endothelial cells which make up blood vessels. Its use could prolong lives, save money, and spare patients exposure to harmful side-effects of ineffective chemotherapy treatments. The effects of various drugs upon endothelial cells can be measured separately from the effects of those same drugs upon cancer cells within the same biopsly specimen.

No one is publishing "real world" studies except laboratories performing cell culture-based tests, which can only do "real world" studies, because their studies require fresh, viable tissue, which must be accessioned and tested in "real time" under "real world" conditions.

Fortunately, receptive people are not so threatened by ideas which dare to challenge and question one-size-fits-all, widgets-on-an-assembly-line medicine. It's certainly not more comforting to see patient after patient succumb, not to the cancer, but to an early demise thanks to wrong-therapy/wrong-dose cookie-cutter treatment.

There are limitations involved with randomized clinical trials. Perhaps the greatest limitation is that it is predictive of population trends, and is not definitive. Clinical trials provide few black and white answers. The problem with the empirical approach is it yields information about how large populations are likely to respond to a treatment. Doctors don't treat populations, they treat individual patients.

Because of this, doctors give treatments knowing full well that only a certain percentage of patients will receive a benefit from any given medicine. They subject patients to one combination chemotherapy after another, just going from one journal paper to another journal paper. They need information about the characteristics that predict which patients are more likely to respond well. The empirical approach doesn't tell doctors how to personalize their care to individual patients.

Source: J Intern Med 2008; 264: 275–287.
gdpawel is offline   Reply With Quote
Old 08-17-2008, 07:39 AM   #5
Jackie07
Senior Member
 
Jackie07's Avatar
 
Join Date: Jan 2008
Location: "Love never fails."
Posts: 5,808
I am having difficulty locating the article with the citation: Journal of Internal Medicine, Volume 64, Pages 275-287. Is it a pre-prepublication? PubMed database lists prepublicated articles but returned zero result when I searched by the citation. The wording does not sound like one from a scholarly journal. There's no matching citation by the key words, either. Is it a 'future' 'letter to the editor'? Who is the author?
__________________
Jackie07
http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2

NICU 4.4 LB
Erythema Nodosum 85
Life-long Central Neurocytoma 4x5x6.5 cm 23 hrs 62090 semi-coma 10 d PT OT ST 30 d
3 Infertility tmts 99 > 3 u. fibroids > Pills
CN 3 GKRS 52301
IDC 1.2 cm Her2 +++ ER 5% R. Lmptmy SLNB+1 71703 6 FEC 33 R Tamoxifen
Recc IIB 2.5 cm Bi-L Mast 61407 2/9 nds PET
6 TCH Cellulitis - Lymphedema - compression sleeve & glove
H w x 4 MUGA 51 D, J 49 M
Diastasis recti
Tamoxifen B. scan
Irrtbl bowel 1'09
Colonoscopy 313
BRCA1 V1247I
hptc hemangioma
Vertigo
GI - > yogurt
hysterectomy/oophorectomy 011410
Exemestane 25 mg tab 102912 ~ 101016 stopped due to r. hip/l.thigh pain after long walk
DEXA 1/13
1-2016 lesions in liver largest 9mm & 1.3 cm onco. says not cancer.
3-11 Appendectomy - visually O.K., a lot of puss. Final path result - not cancer.
Start Vitamin D3 and Calcium supplement (600mg x2)
10-10 Stopped Exemestane due to r. hip/l.thigh pain OKed by Onco 11-08-2016
7-23-2018 9 mm groundglass nodule within the right lower lobe with indolent behavior. Due to possible adenocarcinoma, Recommend annual surveilence.
7-10-2019 CT to check lung nodule.
1-10-2020 8mm stable nodule on R Lung, two 6mm new ones on L Lung, a possible lymph node involvement in inter fissule.
"I WANT TO BE AN OUTRAGEOUS OLD WOMAN WHO NEVER GETS CALLED AN OLD LADY. I WANT TO GET SHARP EDGED & EARTH COLORED, TILL I FADE AWAY FROM PURE JOY." Irene from Tampa

Advocacy is a passion .. not a pastime - Joe
Jackie07 is offline   Reply With Quote
Old 08-17-2008, 07:58 AM   #6
gdpawel
Senior Member
 
gdpawel's Avatar
 
Join Date: Aug 2006
Location: Pennsylvania
Posts: 1,080
The Journal of Internal Medicine is a scholarly journal

Here's your "Platter"

http://www.blackwellpublishing.com/j...54-6820&site=1

Click on View content online

Cell culture detection of microvascular cell death in clinical specimens of human neoplasms and peripheral blood
gdpawel is offline   Reply With Quote
Reply


Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 01:57 PM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter