search
Back to results

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

Primary Purpose

Angiosarcoma

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
mRNA plus Lysate-loaded Dendritic Cell Vaccine
PEGYLATED-INTERFERON ALPHA-2A
Filgrastim
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angiosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation/Deescalation

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
March 23, 2023
Last Updated
October 4, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
Cancer Cures 4 Kids
search

1. Study Identification

Unique Protocol Identification Number
NCT05799612
Brief Title
Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
Official Title
Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Cancer Cures 4 Kids

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angiosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation/Deescalation
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Given by IV (vein)
Intervention Type
Biological
Intervention Name(s)
mRNA plus Lysate-loaded Dendritic Cell Vaccine
Intervention Description
Given by IV (vein)
Intervention Type
Drug
Intervention Name(s)
PEGYLATED-INTERFERON ALPHA-2A
Intervention Description
Given by IV (vein)
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
G-CSF, NeupogenTM
Intervention Description
Given by IV (vein)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vinod Ravi, MD
Phone
(713) 792-1641
Email
vravi@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinod Ravi, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinod Ravi, MD
Phone
713-792-1641
Email
vravi@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Vinod Ravi, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs