Individualized Online Clinical Trial Protocol Version 1.0

[gdpawel]

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

[Jackie07]

Found it!

I wonder if the Weisenthal Group can get a grant from the government or financial backing from pioneers such as Craig Venter to conduct the phase II trial. Most clinical trials seems to be offered free to selected individuals.

But seems I remember some time ago I had located one research article on the particular method used here. I believe it reported a benefit of averaging 3 1/2 months surviving time. (7 months verses 3 1/2 months)

The Weisenthal Group ought to start a media campaign to draw attention and get needed funding and recruits.



Cell culture detection of microvascular cell death in clinical specimens of human neoplasms and peripheral blood
L. M. Weisenthal, N. Patel & C. Rueff-Weisenthal From the Weisenthal Cancer Group, Huntington Beach, CA, USA
Correspondence to Larry M. Weisenthal, Weisenthal Cancer Group, Huntington Beach, CA 92647, USA.
(fax: +714 596 2110; e-mail: mail@weisenthal.org).

Copyright © 2008 Blackwell Publishing Ltd

KEYWORDS
angiogenesis • cancer • cancer chemotherapy • cell biology • endothelial cells • oncology

Weisenthal LM, Patel N, Rueff-Weisenthal C (Weisenthal Cancer Group, Huntington Beach, CA, USA). Cell culture detection of microvascular cell death in clinical specimens of human neoplasms and peripheral blood. J Intern Med 2008; 264: 275–287.

ABSTRACT


Abstract. Background. Angiogenesis studies are limited by the clinical relevance of laboratory model systems. We developed a new method for measuring dead microvascular (MV) cells in clinical tissue, fluid and blood specimens, and applied this system to make several potentially novel observations relating to cancer pharmacology.
Methods. Dead MV cells tend to have a hyperchromatic, refractile quality, further enhanced during the process of staining with Fast Green and counterstaining with either haematoxylin–eosin or Wright–Giemsa. We used this system to quantify the relative degree of direct antitumour versus anti-MV effects of cisplatin, erlotinib, imatinib, sorafenib, sunitinib, gefitinib and bevacizumab.
Results. Bevacizumab had striking anti-MV effects and minimal antitumour effects; cisplatin had striking antitumour effects and minimal anti-MV effects. The `nib' drugs had mixed antitumour and anti-MV effects. Anti-MV effects of erlotinib and gefitinib were equal to those of sunitinib and sorafenib. There was no detectable VEGF in culture medium without cells; tumour cells secreted copious VEGF, reduced to undetectable levels by bevacizumab, greatly reduced by cytotoxic levels of cisplatin + anguidine, and variably reduced by DMSO and/or ethanol. We observed anti-MV additivity between bevacizumab and other drugs on an individual patient basis. Peripheral blood specimens had numerous MV cells which were strikingly visualized for quantification with public domain image analysis software using bevacizumab essentially as an imaging reagent.
Conclusions. This system could be adapted for simple, inexpensive and sensitive/specific detection of tissue and circulating MV cells in a variety of neoplastic and non-neoplastic conditions, and for drug development and individualized cancer treatment.

[gdpawel]

No investor is going to pay for a 3 million dollar phase II or III trial, particularly when there are 800 pharmaceutical in the clinical trials pipeline and there are not enough clinical trial patients to go around.

The methodology of the assays is particularly stringent in that three different cell-death endpoints evaluate the activity of various drugs (up to 30) against the tumor (thus mostly the high cost).

If a laboratory were to perform both IHC and RLB endpoints on each specimen, the overall reliability of the end result would be greatly improved. But the standards of cell culture assays are particularly high.

I personally had thought about Craig Venter and wrote to him. Some have suggested PatientsLikeMe. I had initiated contact with James Heywood. Also Jay M. Tenenbaum of CollabRX.

[gdpawel]

The Musella Foundation's virtualtrials.com is doing something similar to what the Weisenthal Cancer Group is doing. Their brain tumor virtual trial keeps track of patients and displays the results "real time" on the web (virtualtrials.com/volresults).

You select a tumor type (or all tumors to see more data). Then click on a treatment name and you see all patients who took that treatment + each of the other treatments. Click on a number of patients in each group and you get details of the group. Within this group display, click on a patient id and get their details.

But this is the kicker. The Musella Foundation also works on getting insurance companies to pay for these expensive combinations. The most popular one for brain tumors now is cpt-11 and Avastin. It can cost $600,000 a year (perhaps a U.S. Senator could afford that).

The Weisenthal website states there are no one-size-fits-all treatments in this trial and no patient unknowingly receives a placebo instead of a promising new drug he/she had hoped to receive. Patient outcomes will be reported online, in real-time, so patients and cancer physicians will learn immediately if and how patients are benefitting from anti-angiogenic, anti-tyrosine kinase, and standard drug combination therapies identified for them by the new test.

It is the first clinical trial in which novel combinations of emerging drugs are tested for activity in biopsy specimens obtained from each individual patient. While many of these potentially effective drugs are highly expensive, one problem has been in determining in advance who would benefit from them, how to make the drugs more effective by using them in combination. The effectiveness of these drugs can increase exponentially when they are combined with other drugs in various ways.

It is a trial in which each patient receives treatment designed for him/her alone rather than a treatment that serves the financial or research interest of the pharmaceutical company or institution which sponsors traditional clinical trials. Until this new test, no technology existed which allowed for individualized laboratory assessment of candidate drug "combinations" prior to administering them to patients.

[Jackie07]

We need to get some rich people like Warren Buffett and Bill Gates involved. Anybody knows how to start a foundation for Her2 research?