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Cancer Vaccine

PSA/IL-2/GM-CSF vaccine for Prostate Cancer (PSA Trial)

Phase 1
Waitlist Available
Led By Gregory A Daniels, MD, PhD
Research Sponsored by OncBioMune Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to confirmation of disease recurrence. patients undergo bone scans and ct scans of chest, abdomen, and pelvis at pretreatment and then at week 19, and every 24 weeks (6 months) until week 105.
Awards & highlights

PSA Trial 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.

Eligible Conditions
  • Prostate Cancer

PSA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time to confirmation of disease recurrence. patients undergo bone scans and ct scans of chest, abdomen, and pelvis at pretreatment and then at week 19, and every 24 weeks (6 months) until week 105.
This trial's timeline: 3 weeks for screening, Varies for treatment, and time to confirmation of disease recurrence. patients undergo bone scans and ct scans of chest, abdomen, and pelvis at pretreatment and then at week 19, and every 24 weeks (6 months) until week 105. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Adverse Events
Secondary outcome measures
Overall survival
PSA Doubling Time (PSADT) and PAP levels
Time to measurable disease
+2 more

PSA Trial Design

1Treatment groups
Experimental Treatment
Group I: PSA/IL-2/GM-CSF vaccineExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
863 Previous Clinical Trials
227,551 Total Patients Enrolled
38 Trials studying Prostate Cancer
9,156 Patients Enrolled for Prostate Cancer
OncBioMune PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Prostate Cancer
120 Patients Enrolled for Prostate Cancer
Gregory A Daniels, MD, PhDPrincipal InvestigatorUniversity of California, San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients
2012. "Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02058680.
All > Acth > Recurrent Prostate Cancer
~4 spots leftby Apr 2025
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