Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma

NCT05799612 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-0018NCI-2023-02650
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Angiosarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (1)

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

Drug: Paclitaxel; Biological: mRNA plus Lysate-loaded Dendritic Cell Vaccine; Drug: PEGYLATED-INTERFERON ALPHA-2A; Drug: Filgrastim

Interventions

Paclitaxel DRUG

Given by IV (vein)

Dose Escalation/Deescalation

mRNA plus Lysate-loaded Dendritic Cell Vaccine BIOLOGICAL

Given by IV (vein)

Dose Escalation/Deescalation

PEGYLATED-INTERFERON ALPHA-2A DRUG

Given by IV (vein)

Dose Escalation/Deescalation

Filgrastim DRUG

Given by IV (vein)

Also known as: G-CSF, NeupogenTM

Dose Escalation/Deescalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cancer Cures 4 Kids: collaborator

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

Paclitaxel; RNA, Messenger; peginterferon alfa-2a; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; RNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Vinod Ravi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: March 22, 2024
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: February 13, 2026

Record last verified: 2026-02