WithdrawnPhase 1

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

Stopped: No participants enrolled

0Started 2024-03-22

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

Timeframe: through study completion; an average of 1 year

NCT IDNCT05799612

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.