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Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients

NCT02058680 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-09-10

No results posted yet for this study

Summary

This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on survivability, time to measurable disease, prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.

Eligible patients include those with recurrent prostate cancer as shown by elevated levels of PSA, although there is no evidence of tumors that are measurable by imaging studies. In addition, to be eligible patients must have prostate cancer that either has not been treated by hormonal therapy or is not responsive to hormonal therapy.

Conditions

Interventions

BIOLOGICAL

PSA/IL-2/GM-CSF

In Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15. In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • OncBioMune Pharmaceuticals

    lead OTHER

Principal Investigators

  • Jessica Wang-Rodriguez, MD · University of California, San Diego

  • Gregory A Daniels, MD, PhD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

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 NCT02058680 on ClinicalTrials.gov