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Interesting Clinical Trials In Immunotherapy
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CURRENT CLINICAL TRIALS IN IMMUNOTHERAPY:
Now Recruiting in the United States

Last month, we introduced PROVENGE, an immunotherapy, a new type of treatment. We also discussed how immunotherapy works by restarting the patient's immune system, and how it usually has fewer side effects than chemotherapy, or even hormone therapy.

Since immunotherapy is a developing field, there are many immunotherapies becoming available through clinical trials. And since it is challenging to get clear details on these trials, we have chosen a few to share with you. All are currently enrolling. This is not an all inclusive list.

The immunotherapies below include:
ProstAtak
PROVENGE (sipuleucel-T)
Ipilimumab (Yervoy)
ProstVac
A FEW POINTERS ABOUT TRIALS:

It can take 3 to 4 weeks to go through the screening process for a trial. You can usually speed this up by (1) developing a relationship with the clinical trial coordinator or nurse (2) giving them copies of your medical records personally.

Ask the trial coordinator or nurse how this 3-4 week process plays into the timing of some of the eligibility criteria below. Make sure the benefits outweigh the risks for you.

Ask questions about necessary testing, travel, what’s free, and what’s not. Discuss risk vs. benefit with your physician(s) and nurse(s).

Remember, clinical trials are voluntary and you can pull out of a clinical trial any time you want.
PROSTATAK
Phase 3 Study of ProstAtak™ Immunotherapy with Standard Radiation Therapy for Localized Prostate Cancer (PrTK03). Phase 3 – All receive radiation (2/3 receive ProstAtak - 1/3 receive placebo)

Basic Eligibility Criteria:
  • Newly Diagnosed, or Previously Diagnosed, with no local treatment
  • Six months or less of hormone therapy 
  • Intermediate risk PC according to NCCN Guidelines 
or
  • High risk, but with only one high risk feature, according to NCCN Guidelines
  • No metastases

Locations: AZ, CO, MA, MD, NM, NY, PA, TX.

Click here for contact info. Click here to see a recent news video.
PROVENGE (SIPULEUCEL-T)
A Randomized Phase 2 Trial of Combining Sipuleucel-T with Immediate vs. Delayed CTLA-4 Blockade for Prostate Cancer. - Phase 2 – NO Placebo

Basic Eligibility Criteria:
  • Castrate-resistant (on hormone therapy with advancing disease)
  • Metastatic to bone or soft tissue
  • No pain requiring narcotics
  • At least four weeks since other hormonal therapies, including Proscar and Megace.
  • At least four weeks since radiation

Locations: UC San Francisco

Contact: Paula Dutton | 415-885-7871 | walshp@medicine.ucsf.edu
YERVOY
Combining Ipilimumab [Yervoy] with Abiraterone Acetate [Zytiga] Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients with Progressive Metastatic Castration-resistant Prostate Cancer. Phase 2 – NO Placebos

Basic Eligibility Criteria:
  • Castrate-resistant (on hormone therapy with advancing disease)
  • Metastatic
  • NO previous chemotherapy
  • NO previous immunotherapy
  • At least four weeks since Casodex (Bicalutamide)
  • NO previous ketoconazole, Zytiga, or TAK-700
Locations: Memorial Sloan Kettering - NY, NY 

Contact: Dr. Daniel Danila | (646) 422-4612 | Portland. Oregon Health & Science University | Dr. Jeremy Cetnar or Darlene Kitterman | (503) 494-6263 | kitterma@ohsu.edu
PROSTVAC
Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)
Phase 3 – Some men receive placebo

Basic Eligibility Criteria:
  • PSA 2.0 or greater, with two consecutive rises
  • Metastatic to bone or lymph nodes
  • No pain or minimal pain.
  • NO previous chemo
  • NO previous PROVENGE
Locations: 32 States

Contact: Paul Collins | paul.collins@ppdi.com. Janet Hurt | janet.hurt@bavarian-nordic.com. Click here to see a recent video. 



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