Dendritic Cell Vaccine for Skin Cancer

Recruiting in Palo Alto (17 mi)

Overseen byVinod Ravi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

To find the highest tolerable dose of an mRNA vaccine that can be safely given to patients with cutaneous angiosarcoma

Eligibility Criteria

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.

Inclusion Criteria

My kidney, liver, bone marrow, and immune system are functioning well.

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.

I am willing to have a biopsy for vaccine creation.

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Exclusion Criteria

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

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

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

See 5 more

Treatment Details

Interventions

mRNA plus Lysate-loaded Dendritic Cell Vaccine (Cancer Vaccine)
Paclitaxel (Chemotherapy)
PEGYLATED-INTERFERON ALPHA-2A (Interferon)

Trial OverviewThe 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.

Participant Groups

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