I have written much about the need to begin studies of both timing and combining of the many new treatments we have recently developed for the treatment of advanced prostate cancer. With the FDA approval of Provenge, Zytiga, Jevtana, Xtandi and hopefully in the near future Radium-223 Dichloride (Alpharadin) we have many new treatment options available for men with advanced prostate cancer.
Among the many questions we are now faced with is what would happen if we found ways to combine these new treatments? What are the best combinations? We also need to ask what is the best way to sequence these new treatments to maximize their effects? Of course, if we do combine these treatments we will also need to learn how to sequence these combinations to get the best results.
The only way to find these answers is through new, additional clinical trials. Trials that combine these newer treatments and eventually trials that sequence both the drugs and their combinations will be needed to answer these questions.
Putting together and running these trials will take time, money and the willingness of the pharmaceutical companies. Fortunately, we have begun to see these trials starting. These trials will take a massive effort, but an effort that could change the landscape as much as the initial development of the treatments themselves.
Little discussed, but equally important will be trials that look at these new treatments with other drugs not yet approved. These treatments will need to be tested independently and in combinations.
Recently the Georgia Health Sciences University in Augusta, GA, has initiated a new trial of sipuleucel-T (Provenge) in combination with cyclophosphamide and an investigational drug known as CT-011 for the treatment of chemotherapy-naive men with metastatic, castrate-resistant prostate cancer (mCRPC).
According to the clinical trials web page this trial will accrue 57 men who will then be randomized to one of three investigational arms:
• Men in Group A will be treated only with standard sipuleucel-T therapy in three cycles.
• Men in Group B will be treated with sipuleucel-T in three cycles + an intravenous infusion of CT-011 delivered over approximately 2 hours, 2 days after each infusion of sipuleucel-T.
• Men in Group C will be treated with sipuleucel-T in three cycles + intravenous cyclophosphamide (after the first cycle of sipuleucel T only) + an intravenous infusion of CT-011 delivered over approximately 2 hours, 2 days after each infusion of sipuleucel-T.
A press release from the Georgia Health Sciences University describes CT-011 is “a type of antibody that reverses immune suppression caused by cancer.” Since Provenge is an immune system booster the hope is that the CT-011 will support or boost the positive immune response provided by Provenge.
Research has shown that in animal studies that combining Provenge with CT-011 and cyclophosphamide resulted in a significant increase in survival and complete tumor regression in more than 50% of the treated mice.
If you are interested in learning more about this trial contact the referral office of the Georgia Health Sciences University (Tel: 1-888-658-0422). When calling you should refer to this trial by it formal code which is NCT01420965.
Joel T. Nowak, M.A., M.S.W.
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