Clinical trial NCT01347034: Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)
Official title: A Phase II Study Evaluating Neoadjuvant Administration of High Dose Radiation Therapy and Intratumoral Autologous Dendritic Cells in Patients With High-risk Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: radiation
neoadjuvant
intratumoral
autologous
dendritic cells
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2011-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if injection of the participant's our own immune related white blood cells (called dendritic cells) into their tumor will strengthen their immune system to fight against their cancer.


Eligibility criteria: Inclusion Criteria:

* Intermediate or High grade (AJCC 7th edition Grade 3 and 4 or Grade 2 and 3 of a 3 tier system) STS as determined by local pathology diagnostic biopsy specimen review
* Musculoskeletal tumor in extremities, trunk or chest wall
* Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1
* Clinical Stage T2N0M0 (AJCC 7th edition)
* Age ≥18 years at time of consent
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1
* Patient's written study specific, Institutional Review Board (IRB) stamped informed consent.
* Adequate organ function (measured within a week prior to beginning treatment for Arm B and within 2 weeks of beginning treatment for Arm A): white blood count (WBC) \> 3,000/mm³ and absolute neutrophil count (ANC) \>1500/mm³; Platelets \> 100,000/mm³; Hematocrit \> 25%; Bilirubin \< 2.0 mg/dL; Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min
* Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from RT.

Exclusion Criteria:

* Retroperitoneal or Head and Neck primary locations
* Gastrointestinal stromal tumor (GIST)
* Demonstrated metastatic disease
* Contraindication to resection
* Prior RT if the current tumor is locally recurrent after prior resection
* Concurrent treatment with any anticancer agent other than RT as dictated by the protocol
* Prior chemotherapy for the pre-surgical treatment of the primary tumor (neoadjuvant chemotherapy)Bleeding/coagulation disorder
* Human Immunodeficiency Virus (HIV) infection or other primary immunodeficiency disorder
* Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate)
* Steroid therapy within 4 weeks of first DC administration
* Any serious ongoing infection
* Pregnant or lactating women. Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment).

Primary outcomes:
measure: Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)
timeFrame: 11 weeks per participant
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)
timeFrame: 11 weeks per participant
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands University of Florida Department of Radiation Oncology
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville Department of Radiation Oncology
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Alberto Chiappori, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida, Shands Jacksonville
name: Daniel Indelicato, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.