Clinical trial · Interventional
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma
Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's own immune related white blood cells into their tumor would strengthen the immune system to fight against their cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete Resection - Surgery for tumor removal | Procedure | — | UNRESOLVED |
| Dendritic Cell (DC) Injections | Biological | — | UNRESOLVED |
| Radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EBRT + DC Injection + Resection
- description
- Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts as outlined in that intervention.
- interventionNames
- Biological: Dendritic Cell (DC) Injections
- Procedure: Radiation therapy
- Procedure: Complete Resection - Surgery for tumor removal
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 3 years
- description
- Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10\^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Intermediate or high grade sarcoma as determined by pathology review * Musculoskeletal tumor in extremities, trunk or chest wall. * Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter. * Clinical Stage T2N0M0 (AJCC 6th edition) * Patient is not a candidate for neoadjuvant chemotherapy. * Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1. * No steroid therapy within 4 weeks of first dendritic cell administration. * No coagulation disorder. * Patient's written informed consent. * No contraindication to resection. * Adequate organ function (measured within a week of beginning treatment). * White blood count (WBC) \> 3,000/mm to the third power and absolute neutrophil count (ANC) \>1500/mm to the third power * Platelets \> 100,000/mm to the third power * 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 radiation. Exclusion Criteria: * Retroperitoneal location. * Gastrointestinal stromal tumor (GIST). * Demonstrated metastatic disease. * Prior radiation therapy if the current tumor is locally recurrent after prior resection. * Concurrent treatment with any anticancer agent other than radiation as dictated by the protocol. * Bleeding disorder. * H.I.V. infection or other primary immunodeficiency disorder. * Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate). * 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). * ECOG performance status of 2, 3 or 4.
References
Publications (2)
- DERIVEDHong 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. PMID 35135810
- DERIVEDRaj S, Bui MM, Springett G, Conley A, Lavilla-Alonso S, Zhao X, Chen D, Haysek R, Gonzalez R, Letson GD, Finkelstein SE, Chiappori AA, Gabrilovitch DI, Antonia SJ. Long-Term Clinical Responses of Neoadjuvant Dendritic Cell Infusions and Radiation in Soft Tissue Sarcoma. Sarcoma. 2015;2015:614736. doi: 10.1155/2015/614736. Epub 2015 Dec 31. PMID 26880867