Clinical trial · Interventional
Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma
- 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)
The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Connective and Soft Tissue | Connective and Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous dendritic cell vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous dendritic cell vaccine
- description
- Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
- interventionNames
- Biological: Autologous dendritic cell vaccine
Primary outcomes (1)
- measure
- Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
- timeFrame
- 6 month
- description
- Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas
Secondary outcomes (4)
- measure
- Median progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age of 18 or older * ECOG performance score 0 or 1 * Histologically proven soft tissue sarcoma * Unresectable or metastatic soft tissue sarcoma * Ability to give written informed consent * Objective measured and measurable tumor lesions * The failure of standard therapy * Adequate amount of material for genetic research * No active or chronic infection with HIV, Hepatitis B or Hepatitis C * Men/Women of childbearing potential must use adequate contraception * Hematology, liver function and renal function lab tests within required parameters Exclusion Criteria: * Untreated or uncontrolled brain metastases. * History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma. * Autoimmune disease (vitiligo is not a basis for exclusion). * Serious uncontrolled medical disorder or active infection that would impede treatment. * Underlying medical or psychiatric condition that would cause administration vaccine * Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine * Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed). * Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements. * Pregnant or breastfeeding women. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.
References
Publications (0)
Data not yet available