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Posts Tagged ‘prostate cancer trials’
LATEST POSTS
- 03/18/2010 - CTL Sends FDA’s Sharfstein Letter Requesting Promised but Undelivered Expedited Review
- 03/03/2010 - Dendreon’s Provenge - 40% Increased Survival - “New Treatment Paradigm” for Cancer!
- 02/27/2010 - Is the FDA Protecting or Hurting Us?
- 02/25/2010 - CTL Files a Reply in The United States Court of Appeals
- 02/24/2010 - Ohio House of Rep Tiberi makes Congressional Inquiry into Provenge’s FDA History
- 02/19/2010 - CTL Attorney Kerry Donahue Gets Pro Bono Award For Provenge Cancer Treatment Advocacy
- 02/02/2010 - NCI Denies CareToLive Freedom of Information Act Appeal
- 01/11/2010 - CBER Responds To Letter From CareToLive
- 01/08/2010 - Now Public - CBER Gone Fishing While Men Gone Wishing
- 01/02/2010 - CareToLive Attorney Kerry Donahue’s Op-Ed Published on Now Public — Men Don’t Have the Luxury of Waiting
MOST POPULAR
- Sleepless in Asentar
- Michael Milken and the Prostate Cancer Foundation's Foul Balls
- The FDA is uncaring, the world won’t change their thought process and meanwhile Congress remains asleep at the wheel, when it comes to Provenge for the terminally ill.
- Supplemental Memorandum Plaintiff CareToLive
- Corruption at Its Finest
- 3 "Leaked" Letters & So Much More
- CareToLive Writes to Interim FDA Commissioner Dr. Frank Torti
- Get On The Bus Gus!
- FDA Creates Human Ticking Time Bombs
- Madoff Whistleblower Harry Markopolos Tells Congress FDA Is Captured!
WHATS GOING ON
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
Nov 23, 2009 Newer Provenge (Sipuleucel-T) Clinical Trial Recruiting Men in Six States
November 25th, 2009 | Posted by CTLWhile Provenge (Sipuleucel-T) is not yet FDA approved, it may be available in a new Dendreon-sponsored multicenter, open label (no placebo), phase 2 study for men with metastatic castrate-resistant prostate cancer, if a man fits the eligibility requirements. (Note: This trial is different from the previous ProACT trial, which used lower concentrations of Sipuleucel-T, and required that men live close to the trial site). The trial is also available to those men who received placebo during the previous trial.
Some basic criteria (see link below for the full list) for being considered include having:
Metastatic disease
Castrate-resistant prostate cancer (this means men who no longer respond to surgical or medical castration, such as hormone therapy)
PSA of at least 5.0 ng/mL
(* NOTE - watch for this criteria to change in a few days. )
watch at http://www.clinicaltrials.gov/ct2/show/NCT00901342?term=provenge&recr=Open&rank=2
Castrate level of testosterone (less than 50 ng/dL) achieved via medical or surgical castration
Life expectancy of at least 3 months
Adequate hematologic, renal and liver function
No lung, liver, or brain metastases
It must also be at least 28 days since a man has: used systemic corticosteroids (use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, less than or equal to 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans); used non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide); had external beam radiation therapy or major surgery requiring general anesthetic; had any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace), diethylstilbestrol (DES), and ketoconazole; received chemotherapy; or had treatment with any other investigational product.
Current trial sites include Park Ridge, Illinois; Greenbelt, Maryland; Durham, North Carolina; Norfolk, Virginia; New York, New York; and Seattle, Washington. Men must contact the trial site they are interested in to find out if they meet all the criteria. To learn more, including the phone numbers of the trial sites, click here>>
Link to Trial: http://www.clinicaltrials.gov/ct2/show/NCT00901342?term=provenge&recr=Open&rank=2Video re: Provenge - http://activation.dendreon.com
Popularity: 34%
Tags: Dendreon, Prostate Cancer, prostate cancer trials, provenge, sipuleucel-t
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