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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

No Placebo-Only Group

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 below

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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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (i.e. up to 1 year post initial vaccine) for reporting.