Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 21, 2011

Primary Completion Date

November 28, 2022

Study Completion Date

November 28, 2022

Conditions
Malignant Solid TumourBreast CancerMalignant Tumor of ColonGISTOvarian Cancer
Interventions
BIOLOGICAL

HER-2 vaccine

Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified with nor-MDP in ISA 720 vehicle. Increasing doses of the combined vaccine preparation emulsified with nor-MDP (0.025) mg and Montanide ISA 720 will be administered in a final volume of 1.0 ml. Starting at dose level 1, 1.0mg of each peptide will be used for vaccination. In increasing dosing cohorts 1.5mg, 2.0mg and 2.5mg will be used. Patients may also receive 6 months booster shots.

BIOLOGICAL

Extension HER-2 vaccine trial at OBD

Three intramuscular (IM) injections (separated by 21 days) of a mixture of two peptides {MVF-HER-2(597-626) and MVF-HER-2 (266-296)} vaccine emulsified with nor-MDP in ISA 720 vehicle. The dose level has been determined to be cohort 2. The combined vaccine preparation consists of 1.5mg of each of the HER-2 vaccine emulsified with nor-MDP (0.025) mg and Montanide ISA 720 will be administered in a final volume of 1.0 ml. Patients may also receive 6 months booster shots.

Trial Locations (1)

43210

Ohio State University Medical Center, Columbus

All Listed Sponsors
lead

Robert Wesolowski

OTHER

NCT01376505 - Vaccine Therapy in Treating Patients With Metastatic Solid Tumors | Biotech Hunter | Biotech Hunter