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A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer

NCT02293707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-07-22

No results posted yet for this study

Summary

GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme playing an essential role in cancer cell proliferation.

This clinical trial will test three different GX301 administration regimens in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination regimen.

The three regimens will primarily be compared for their efficacy and safety in inducing vaccine-specific immunological responses over a period of 6 months following treatment initiation. In addition, patients will be observed for the occurrence of disease progression and for their vital status up to 24 months.

Conditions

Interventions

BIOLOGICAL

GX301

GX301 therapy consists of four human telomerase reverse transcriptase (hTERT) peptides and two adjuvants. Peptides are hTERT (540-548) Acetate, hTERT (611-626) Acetate, hTERT (672-686) Acetate and hTERT (766-780) Acetate. Adjuvants are Montanide ISA 51 VG and imiquimod 5% cream (Aldara). Each GX301 administration will consist of four intradermal injections - one injection for each hTERT peptide - given at the same time and followed by topical application of imiquimod. Each intradermal injection will consist of a fixed hTERT peptide dose, 500 µg, reconstituted as a solution and mixed with Montanide ISA 51 VG.

Sponsors & Collaborators

  • Universita degli Studi di Genova

    collaborator OTHER

  • Laboratoires Leurquin Mediolanum

    lead INDUSTRY

Principal Investigators

  • Francesco Boccardo, MD · DIMI, Università di Genova - Clinica di Oncologia Medica, IRCCS San Martino-IST

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-08-31
Completion
2019-11-30

Countries

  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293707 on ClinicalTrials.gov