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Cancer Vaccine
Vaccine Therapy for Breast Cancer
Phase 1
Waitlist Available
Led By Pravin Kaumaya, PhD
Research Sponsored by Pravin T.P Kaumaya
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For the extension cohort at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled
Patients are required to have HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC) to be enrolled on this study
Must not have
Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive
Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (i.e. up to 1 year post initial vaccine)
Awards & highlights
Summary
This trial is testing a new vaccine treatment for patients with advanced cancer to see how safe it is and what dosage works best. The vaccine is made from antibodies, peptides, and tumor cells, and it
Who is the study for?
This trial is for patients with metastatic solid tumors, specifically those with breast cancer or gastrointestinal cancers that show an overexpression of a protein called Epidermal Growth Factor Receptor (EGFR).
What is being tested?
The study is testing vaccine therapy combining two peptides, MVF-HER-2 (597-626) and MVF-HER-2 (266-296), mixed with ISA 720 to see if it can stimulate the immune system to destroy tumor cells.
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, and possibly allergic responses due to the body's heightened immune activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have breast or gastrointestinal cancer that cannot be removed by surgery.
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My cancer shows HER-2 or EGFR over-expression.
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I had brain metastases treated, off steroids, and stable for 3+ months.
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I am 18 years old or older.
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My heart's pumping ability is normal or above 50%.
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My blood counts and liver/kidney functions are within normal ranges.
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I have breast or gastrointestinal cancer that cannot be removed by surgery and at least one tumor that can be measured.
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I can walk and care for myself with little to no assistance.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to specific components used in the trial.
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I have been off antibiotics for 3 weeks and am clear of infection.
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I have had my spleen removed.
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I have an active autoimmune disease like rheumatoid arthritis or lupus.
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I do not need steroids or other immune-weakening drugs for another health issue.
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My cancer does not show HER-2 or has low EGFR based on tests.
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I am currently on targeted therapies like CDK 4/6 or mTOR inhibitors with hormone therapy.
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I do not have active HIV, hepatitis A, B, or C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (i.e. up to 1 year post initial vaccine)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (i.e. up to 1 year post initial vaccine)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0
Humoral Immune Response
Overall Response Rate
Secondary outcome measures
T cell functionality
immunogenicity
Trial Design
2Treatment groups
Experimental Treatment
Group I: HER-2 vaccine GIExperimental Treatment1 Intervention
Group II: HER-2 vaccine BreastExperimental Treatment1 Intervention
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Who is running the clinical trial?
Pravin T.P KaumayaLead Sponsor
Pravin Kaumaya, PhDPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Breast Cancer
65 Patients Enrolled for Breast Cancer
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