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Cancer Vaccine

Dendritic Cell Vaccine for Skin Cancer

Phase 1

Recruiting

Led By Vinod Ravi, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with histologically confirmed cutaneous head & neck angiosarcoma deemed to be potentially resectable and who are deemed to be good candidates for postoperative therapy with radiation and study treatment

Should be willing to undergo biopsy to provide fresh frozen tumor tissue for use in the creation of the vaccine

Must not have

Received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial

Uncontrolled HIV infection with CD4+ <200 cells/µl or active HBC or HCV disease that requires antiviral therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test what dose of mRNA vaccine is safe to give to people with skin cancer.

Who is the study for?

This trial is for adults with a skin cancer called cutaneous angiosarcoma on the head & neck, which can be surgically removed. Participants must have good kidney, liver, and bone marrow function and not be on immunosuppressants or have autoimmune diseases. Pregnant women and those who might become pregnant without testing are excluded.

What is being tested?

The study aims to determine the highest dose of an mRNA vaccine that's safe for patients with cutaneous angiosarcoma when combined with Paclitaxel, PEGYLATED-INTERFERON ALPHA-2A, Filgrastim treatments. It involves creating a personalized vaccine from the patient's own tumor tissue.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms due to interferon and filgrastim, allergic reactions to paclitaxel including low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I have a type of skin cancer in my head or neck area that can be surgically removed and I am considered a good candidate for follow-up treatment.

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I am willing to have a biopsy for vaccine creation.

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I am 18 or older and can give my consent.

Exclusion Criteria

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

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I have not received any live vaccines in the last 30 days.

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I have HIV with low CD4+ counts or active hepatitis needing treatment.

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I require steroids or immunosuppressants during the study's vaccination phase.

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I am not pregnant, breastfeeding, and if of childbearing potential, I have a negative pregnancy test.

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My cancer cannot be removed by surgery and/or has spread to other parts of my body.

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation/DeescalationExperimental Treatment4 Interventions

Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Filgrastim

2000

Completed Phase 3

~3690

Paclitaxel

2011

Completed Phase 4

~5370