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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799612

Collaborator

Cancer Cures 4 Kids (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Angiosarcoma	Drug: Paclitaxel Biological: mRNA plus Lysate-loaded Dendritic Cell Vaccine Drug: PEGYLATED-INTERFERON ALPHA-2A Drug: Filgrastim	Phase 1

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

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation/Deescalation 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 Given by IV (vein) Biological: mRNA plus Lysate-loaded Dendritic Cell Vaccine Given by IV (vein) Drug: PEGYLATED-INTERFERON ALPHA-2A Given by IV (vein) Drug: Filgrastim Given by IV (vein) Other Names: G-CSF NeupogenTM

Arm

Intervention/Treatment

Experimental: Dose Escalation/Deescalation

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

Given by IV (vein)

Biological: mRNA plus Lysate-loaded Dendritic Cell Vaccine

Given by IV (vein)

Drug: PEGYLATED-INTERFERON ALPHA-2A

Given by IV (vein)

Drug: Filgrastim

Given by IV (vein)

Other Names:

G-CSF

NeupogenTM

Outcome Measures

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 [through study completion; an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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
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.

Exclusion criteria:

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.