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Cancer Vaccine

HER-2 vaccine for Gastrointestinal Stromal Tumor

Q: When will the HER-2 vaccine be able to be sold commercially?

<p>The limited data available for HER-2 <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a>'s safety and efficacy resulted in it receiving a score of 1.</p>

Phase 1

Waitlist Available

Led By Robert Wesolowski, MD

Research Sponsored by Robert Wesolowski

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 up to 6 months

Awards & highlights

Study Summary

This trial is testing a new cancer vaccine to see if it is safe and effective. The vaccine is made from antibodies and peptides combined with tumor cells. Researchers want to see if the vaccine can help the body build an effective immune response to kill tumor cells.

Eligible Conditions

Cancer
Gastrointestinal Stromal Tumor
Breast Cancer
Ovarian Cancer
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical benefit will be assessed

Type and duration of immune response measured over time to repeat vaccine administration

Secondary outcome measures

Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria (CTCAE v 4.0)

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

13%

Upper Respiratory Infection

12%

COVID-19 Infection

Chronic Obstructive Pulmonary Disease (COPD) exacerbation

Hepatocellular Carcinoma

Hospitalization for pacemaker due to arrhythmia

Revision of right shoulder rotator cuff surgery

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Trial Design

2Treatment groups

Experimental Treatment

Group I: HER-2 VaccineExperimental Treatment1 Intervention

combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with nor-MDP and ISA 720 This escalation arm has completed. The trial has moved on to the extension arm

Group II: EXTENSION HER-2 Vaccine at OBDExperimental Treatment1 Intervention

Combination of MVF-HER-2 (597-626) and MVF-HER-2 (266-296) emulsified with nor-MDP and ISA 720 at dose level cohort 2 This extension arm is ongoing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Measles virus vaccine live attenuated

FDA approved

Extension HER-2 vaccine trial at OBD

2011

Completed Phase 1

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Robert WesolowskiLead Sponsor

Pravin KaumayaLead Sponsor

Robert Wesolowski, MDPrincipal InvestigatorOhio State University

1 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

Gastrointestinal Stromal Tumor Research Study Groups: HER-2 Vaccine, EXTENSION HER-2 Vaccine at OBD

Gastrointestinal Stromal Tumor Clinical Trial 2023: Extension HER-2 vaccine trial at OBD Highlights & Side Effects. Trial Name: NCT01376505 — Phase 1

Extension HER-2 vaccine trial at OBD (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01376505 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide a list of other HER-2 vaccine clinical trials?

"There are currently 8 ongoing clinical trials studying the HER-2 vaccine. One of these live trials is in Phase 3 while the rest are in different stages of research. The majority of studies related to the HER-2 vaccine take place in Rochester, Minnesota; however, there are 70 locations running trials for this treatment across the United States."

Answered by AI

Are researchers still looking for participants in this experiment?

"The search for participants is still ongoing, as noted on clinicaltrials.gov. This study was first posted June 21st, 2011 and updated October 27th, 2020."

Answered by AI

When will the HER-2 vaccine be able to be sold commercially?

"The limited data available for HER-2 vaccine's safety and efficacy resulted in it receiving a score of 1."

Answered by AI

How many people can be a part of this experiment at most?

"That is correct. The listing on clinicaltrials.gov indicates that the research team is currently looking for 100 individuals to take part in the study at a single site. This trial was first made public on 6/21/2011 and updated as recently as 10/27/2022."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Phase I Immunotherapy Trial with Two Chimeric HER-2 B-cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-mdp Adjuvant in Patients with Advanced Solid Tumors

Bekaii-Saab, Tanios, Robert Wesolowski, Daniel H. Ahn, Christina Wu, Amir Mortazavi, Maryam Lustberg, Bhuvaneswari Ramaswamy, et al.. 2019. “Phase I Immunotherapy Trial with Two Chimeric HER-2 B-cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-mdp Adjuvant in Patients with Advanced Solid Tumors”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-18-3997.

Clinical Cancer ResearchJournal

Phase I Immunotherapy Trial with Two Chimeric HER-2 B-cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-mdp Adjuvant in Patients with Advanced Solid Tumors

clinicaltrials.govStudy

Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

Robert Wesolowski 2011. "Vaccine Therapy in Treating Patients With Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01376505.