I now have some additional information about the Early/Expanded Access Program for Enzalutamide (MDV-3100)for men with advanced prostate cancer. Jan Manarite, who is a member of the Early Access Committee has provided the following information:
From the Early/Expanded Access Committee – Now available in 10 states (see list below in this post) with additional states anticipated in the near future.
The goal of the access program is to provide expanded access to MDV3100 and to monitor its safety in men with progressive castration-resistant advanced prostate cancer previously treated With docetaxel based chemotherapy. In this trial there will be no placebo and no cost for MDV3100 (check with trial site for any other costs).
Basic Eligibility Criteria:
CRPC/HRPC – on hormone therapy with progressive disease
Metastatic advanced prostate cancer
NO small cell or neuroendocrine features
Previously treated with Taxotere (docetaxel)
No brain metastases
HGB 9.0 or higher
No history of stroke or seizure
No significant cardiovascular disease
If you think you fit the above Criteria, contact one of the sites below for further criteria and screening.
Locations:
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Alaska
Alaska Clinical Research Center, LLC
Contact: Robin Adams (907) 276-1455
Anchorage, Alaska 99508
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Arizona
Pinnacle Oncology/Hematology
Contact: Sherril Bierman (480) 278-8804
Scottsdale, AZ 85258
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California
Prostate Oncology Specialists
Contact: Jennifer Leung (310) 827-7707
Marina del Rey, CA 90292
Dr Ronald Yanagihara
Contact: Katrina or Lara (408) 847-6194
Gilroy, CA 95020
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Indiana
Investigative Clinical Research of Indiana LLC
Contact: Leslie Weitman (317) 716-0323
Indianapolis, IN, 46260
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Mississippi
Jackson Oncology Associates, PLLC
Contact: Teresa Davis (601) 974-5547
Jackson, Mississippi, 39202
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New Hampshire
New Hampshire Oncology Hematology PA
Contact: Margaret White (603) 224-2556 x 1323
Hooksett, New Hampshire, 03106
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New York
Accumed Research Associates
Contact: Tammi Allegra (516) 746-2190
Garden City, New York, 11530
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North Carolina
Cancer Centers of North Carolina
Contact: Julia Berry (919) 781-7070
Raleigh, North Carolina, 27607
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South Carolina
Charleston Hematology Oncology Associates, PA
Contact: Deborah McNeal (843) 266-2540
Charleston, South Carolina, 29414
Carolina Urologic Research Center
Contact: Tabitha Joyner (843) 449-1010 x228
Myrtle Beach, South Carolina, 29572
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Virginia
Virginia Oncology Associates
Contact: Wendi Gobhardt (757) 213-5813
Norfolk, VA, 23502
* Enrollment Tip – ?It often takes a few weeks to complete the enrollment and screening process for an expanded access trial. You may be able to speed up this process by supplying the clinical trial nurse with your own medical records, which may relieve him/her from trying to obtain them from another clinic. Factor all of this into your decisions. As always, discuss with your physician(s).
Joel T Nowak, M.A., M.S.W.
The Zytiga that i am now taking is failing, the MDV-3100 is my last hope of some future and my prostrate cancer is very aggressive. Please get this process at the
UT Southwest Cancer Center.
Attn. to Dr. Nima Sharifi
Please, HELP !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
My husband, Tom (age 60), had his cancerous prostate removed in 2008 (at age 56), is on Lupron, but the prostate cancer has metastisized to his bones and liver. We have tried four types of chemo since Nov. 2011 (including Zytiga) without effective results. We are holding onto the hope that MDV3100 will be available and will help him!!! Please, can he be part of a clinical trial now so he can get started on this treatment without waiting until it is in the retail market? Please help us! Thank you! Bell O’Neil from Franklin, PA
We see Dr. Appleman at the Hillman Cancer Center in Pittsburgh, PA
Bell, The post which you responded to has a description on how your husband might be able to get MDV3100 NOW. Read the post and then if you have a question let me know.
Joel