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Cancer Vaccine

Prostate Cancer Vaccine for Prostate Cancer

Phase 2

Waitlist Available

Led By James L. Gulley, MD, PhD, FACP

Research Sponsored by Kael-GemVax Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No immunocompromised status due to HIV positivity or active autoimmune diseases

No life-threatening illnesses

Must not have

No concurrent topical steroids or systemic steroids

No concurrent alternative medications known to alter PSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is comparing a vaccine made from tumor cells to a placebo in treating patients with stage D0 prostate cancer.

Who is the study for?

Men with early-stage prostate cancer (Stage D0) who have a life expectancy of at least 6 months, normal organ and marrow function, no other active cancers in the last 5 years except certain skin or bladder cancers. They must not have serious illnesses that could affect treatment adherence, be HIV positive, or have severe autoimmune diseases.

What is being tested?

This phase II trial is testing whether vaccines made from tumor cells are more effective than a placebo at stimulating the immune system to destroy prostate cancer cells. Patients will either receive the BCG vaccine, a new prostate cancer vaccine called ONY-P1, or a placebo.

What are the potential side effects?

Possible side effects may include typical vaccine reactions like soreness at injection site, fever, fatigue. There's also potential for an allergic reaction to components of the vaccines and immune-related responses due to activation against body's own tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have HIV or active autoimmune diseases.

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I do not have any illnesses that could threaten my life.

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My prostate cancer has been confirmed by a biopsy.

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My prostate cancer diagnosis is confirmed by a pathologist, or my clinical signs match prostate cancer if no biopsy was done.

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I have no known allergies or adverse reactions to BCG vaccine.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using any steroid creams or taking steroid pills.

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I am not taking any alternative medications that affect PSA levels.

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I am not taking any medication for urinary symptoms.

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I am not on any other hormonal treatments.

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I have never received chemotherapy.

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I am not receiving any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IExperimental Treatment2 Interventions

Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm IIPlacebo Group1 Intervention

Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BCG vaccine

FDA approved

0 / 12Eligibility criteria met