AngiosarcomaPhase 1NCT05799612
Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
A Phase 1 study testing Paclitaxel, mRNA plus Lysate-loaded Dendritic Cell Vaccine and PEGYLATED-INTERFERON ALPHA-2A in people with Angiosarcoma, run by M.D. Anderson Cancer Center.
Trial summary
To find the highest tolerable dose of an mRNA vaccine that can be safely given to patients with cutaneous angiosarcoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiosarcoma
- What is being tested?
- Paclitaxel, mRNA plus Lysate-loaded Dendritic Cell Vaccine and PEGYLATED-INTERFERON ALPHA-2A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2024to 5 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 years of age or older and able to provide informed consent.
- Adequate kidney, liver, bone marrow function, and immune function, as follows:
- Hemoglobin ≥ 8.0 gm/dL
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
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- Lymphocytes ≥ 500 cells/mm3
- Platelet count ≥ 75,000 /mm3
- CD4+ T-cell counts ≥ 200/mm3
- Glomerular filtration rate (GFR) > 60 mL/min/m2
- For males = (140 - age[years]) x (body weight [kg]) (72) x (serum creatinine [mg/dL]
- For females = 0.85 x male value
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
- Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
- TSH range between 0.4 - 4.0 mIU / L
- aPTT or INR ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. If receiving anticoagulant therapy, patient is eligible as long as prothrombin time, international normalized ratio (INR), or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
- ECOG performance status ≤ 2.
Who cannot join
- Locally advanced tumors deemed unresectable and/or metastatic tumors
- Received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.
- Uncontrolled HIV infection with CD4+ <200 c ells/µl or active HBC or HCV disease that requires antiviral therapy.
- Need for concurrent therapy with corticosteroids or any systemic immunosuppressive agents during the vaccination phase of the study.
- History of systemic autoimmune disease
- Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions (refer Table 1) throughout the trial and 3 months following discontinuation of study treatment. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first treatment.
- Concurrent participation on another therapeutic clinical trial.
- Patients unwilling or unable to comply with the protocol or provide informed consent.
About this study
To find the highest tolerable dose of an mRNA vaccine that can be safely given to patients with cutaneous angiosarcoma
Read the detailed description
Objectives:
Primary objective:
•To determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with tumor lysate plus mRNA to patients with cutaneous head \& neck angiosarcoma as adjuvant therapy.
Secondary objective:
- To assess the recurrence free survival and overall survival in treated patients in order to make initial assessment of activity of this therapeutic approach
Exploratory Objectives:
- To quantitate immune responses in patients who receive autologous DCs loaded with tumor lysate plus mRNA
- Conditions
- Angiosarcoma
- Being tested
- Paclitaxel, mRNA plus Lysate-loaded Dendritic Cell Vaccine, PEGYLATED-INTERFERON ALPHA-2A, Filgrastim
- Medical subject headings
- Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Given by IV (vein)
mRNA plus Lysate-loaded Dendritic Cell VaccineBiological
Given by IV (vein)
PEGYLATED-INTERFERON ALPHA-2ADrug
Given by IV (vein)
FilgrastimDrug
Also called G-CSF, NeupogenTM
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation/Deescalation | Experimental | 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 Receives: Drug: Paclitaxel; Biological: mRNA plus Lysate-loaded Dendritic Cell Vaccine; Drug: PEGYLATED-INTERFERON ALPHA-2A; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start22 Mar 2024
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Nov 2024 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiosarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Cures 4 Kids
- Responsible party
- Sponsor
- Investigators
- Vinod Ravi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799612
- Sponsor's protocol ID
- 2021-0018
- Other IDs
- NCI-2023-02650
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
- ClinicalTrials.gov ID
- NCT05799612
- Acronym / sponsor ID
- 2021-0018
- Conditions
- Angiosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Cures 4 Kids
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Nov 2024 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find the highest tolerable dose of an mRNA vaccine that can be safely given to patients with cutaneous angiosarcoma
Detailed description
Objectives:
Primary objective:
•To determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with tumor lysate plus mRNA to patients with cutaneous head \& neck angiosarcoma as adjuvant therapy.
Secondary objective:
- To assess the recurrence free survival and overall survival in treated patients in order to make initial assessment of activity of this therapeutic approach
Exploratory Objectives:
- To quantitate immune responses in patients who receive autologous DCs loaded with tumor lysate plus mRNA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation/Deescalation | Experimental | Drug: Paclitaxel, Biological: mRNA plus Lysate-loaded Dendritic Cell Vaccine, Drug: PEGYLATED-INTERFERON ALPHA-2A, Drug: FilgrastimParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- 18 years of age or older and able to provide informed consent.
- Adequate kidney, liver, bone marrow function, and immune function, as follows:
- ECOG performance status ≤ 2.
Key exclusion criteria (8 listed)
- Locally advanced tumors deemed unresectable and/or metastatic tumors
- Received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.
- Uncontrolled HIV infection with CD4+ <200 c ells/µl or active HBC or HCV disease that requires antiviral therapy.
- Need for concurrent therapy with corticosteroids or any systemic immunosuppressive agents during the vaccination phase of the study.
- History of systemic autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelGiven by IV (vein) | Drug | Dose Escalation/Deescalation |
| mRNA plus Lysate-loaded Dendritic Cell VaccineGiven by IV (vein) | Biological | Dose Escalation/Deescalation |
| PEGYLATED-INTERFERON ALPHA-2AGiven by IV (vein) | Drug | Dose Escalation/Deescalation |
| FilgrastimAlso: G-CSF, NeupogenTMGiven by IV (vein) | Drug | Dose Escalation/Deescalation |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinod Ravi, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel, mRNA plus Lysate-loaded Dendritic Cell Vaccine and PEGYLATED-INTERFERON ALPHA-2A in people with Angiosarcoma, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.