GUMDROP : NCI 11-C-0247 A randomized phase II study of L-BLP25 in combination with standard androgen deprivation therapy and radiation therapy for newly diagnosed, high risk prostate cancer patients.

Description:

L-BLP25 is a liposome vaccine that targets the MUC1 tumor-associated antigen. A pilot trial in prostate cancer showed a good safety profile and early evidence of clinical activity. This is a randomized, open-label phase II study to determine the impact of the L-BLP25 vaccine in addition to standard treatment with ADT and radiation therapy on the MUC1-specific systemic immune response (measured by ELISPOT at baseline, 2 months and 6 months after radiation) in patients with newly diagnosed high risk prostate cancer compared to patients receiving standard treatment alone. Secondary outcome measures are time to progression and immunologic responses in the tumor microenvironment. An exploratory endpoint is evaluation of response or recurrence using endorectal MRI.

Link:

http://www.clinicaltrials.gov/ct2/show/NCT01496131

Site:

NCI

Principal Investigator:

Ravi Madan

Additional Information:

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