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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am willing to have a biopsy for vaccine creation.
Select...
I am 18 or older and can give my consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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
~3670
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,452 Total Patients Enrolled
2 Trials studying Hemangiosarcoma
81 Patients Enrolled for Hemangiosarcoma
Cancer Cures 4 KidsUNKNOWN
Vinod Ravi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have not received any live vaccines in the last 30 days.I am 18 or older and can give my consent.I have HIV with low CD4+ counts or active hepatitis needing treatment.I require steroids or immunosuppressants during the study's vaccination phase.You have a history of a serious autoimmune disease affecting your whole body.I am not pregnant, breastfeeding, and if of childbearing potential, I have a negative pregnancy test.My cancer cannot be removed by surgery and/or has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation/Deescalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial need more participants at present?
"Unfortunately, the study is no longer open for recruitment. As detailed on clinicaltrials.gov, this trial was first posted on September 30th 2023 and last amended on March 23rd of the same year. Nevertheless, there are still 19 other studies that are actively enrolling volunteers right now."
Answered by AI
What potential risks do individuals face when undergoing Dose Escalation/Deescalation?
"Our team at Power gave Dose Escalation/Deescalation a score of 1 due to it being in the early stages of clinical trials and therefore having limited efficacy data."
Answered by AI
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