NCT01390064

Vaccination of High Risk Breast Cancer Patients

Phase 1 Safety Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDE ISA 51 VG Adjuvant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon immunization of breast cancer subjects.

Detailed description

After signing Institutional Review Board (IRB) approved consent, cohorts of 3-6 stage IV breast cancer subjects will be enrolled into the study. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous (SC) injections of the vaccine on 5 separate occasions during Weeks 1, 2, 3, 7, and 19. The first cohort will begin with the 300 mg dose, and then the subsequent cohorts will escalate to 500 mg or de-escalate to 100 mg as determined by the toxicity criteria. The immunization at week 19 is considered a booster immunization. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last for approximately 12 - 24 months.

Conditions

• Stage IV Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG	All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule

Timeline

• Start date: 2011-07-01
• Primary completion: 2018-07-01
• Completion: 2019-07-01
• First posted: 2011-07-08
• Last updated: 2019-08-20
• Results posted: 2019-06-03

Locations

1 site across 1 country: United States