CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
degarelix acetate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01696877
NCT01696877Phase 2Completed

A Neoadjuvant Immunologic Study of Androgen Deprivation Therapy Combined With a Granulocytemacrophage-colony Stimulating Factor F-secreting Allogeneic Prostate Cancer Vaccine and Low-dose Cyclophosphamide in Men With High-risk Localized Prostate Cancer Undergoing Radical Prostatectomy

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Oct 1, 2012·Updated Mar 28, 2019

In Brief

A Phase 2 clinical trial evaluating degarelix acetate, Cyclophosphamide, and 1 other intervention for Prostate Cancer Adenocarcinoma in Situ. Completed, enrolled 29 participants across 1 site.

Detailed Summary

This research is being done to see if an investigational prostate cancer vaccine, called GVAX, can safely be given together with a single intravenous injection of a drug called cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands who have also received standard hormonal therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 1, 2012
Enrollment StartJan 18, 2013
Primary CompletionAug 1, 2017
Study CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.8 years ago

Interventions

degarelix acetatedrug

Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.

Cyclophosphamidedrug

Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.

GVAXdrug

GVAX is granulocytemacrophage -colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer