Drug Repurposing for Advanced PC 13. Immunotherapies

Hi Jim-

It's a good question that no one will be able to answer with confidence.

It seems to me that conceptually you want your immune system to be supercharged by the Provenge to be ready when the SBRT begins blasting all the cancer antigens into your bloodstream. Not all the cancer cells are killed directly by the radiation - some are implanted with "time bombs" that explode later, up to several years later. The immune enhancement from Provenge hangs around for quite some time, so I don't think that precision timing is all that critical. Leukocytes that learn to recognize cancer antigens "teach" the skill to other leukocytes, and it becomes part of the immune system's "memory." So it seems to me that you have a wide window of opportunity. Your before/during/after plan looks great to me in concept.

In the following study using a different immune enhancer (PSA-seeking cowpox + metronomic IL-2 + Leukine), men were given 8 monthly cycles and were treated with radiation after the third cycle, utilizing a before/during/after plan like yours.

Safety and Immunologic Response of a Viral Vaccine to PSA in Combination with Radiation Therapy when Metronomic-Dose IL-2 Is Used as an Adjuvant

With your immune boosting, androgen ablation, and SBRT, you are a Triple Threat to your cancer.

I said that your before/during/after plan sounds good to me. You want those enhanced leukocytes hungry and ready to gobble up and produce antibodies against the cancer antigens when they're at their prime. I only meant that you have some leeway in timing because the leukocytes hang around for a while.

Another very important immunotherapy just became available off label. Pembrolizumab (Keytruda) is a monoclonal antibody that blocks a cancer cell surface protein called PD-1. PD-1 prevents the immune system from attacking the cancer. While the FDA just approved it for malignant melanoma after "ipi" failure, it can now be repurposed for advanced prostate cancer. I'm sure the cost will be sky high.

Specifically for prostate cancer, there is a clinical trial (NCT01420965) of an anti-PD-1 together with Provenge and low dose cyclophosphamide at Georgia Regents University in Augusta. They completed Phase I, which is antibody response to Provenge, and are just starting on Phase II randomization to the other treatments. They are about to expand to two more sites in Knoxville, TN, and Athens, GA, and are trying to find other sites as well. After 5 weeks of treatment, they have patients come in every 6 weeks for monitoring.

Another trial of Keytruda, this time coupled with another investigational immunotherapy called ADXS-PSA, has been announced but is not yet recruiting.

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