Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Kidney Cancer
Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): change in corporate priorities
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney 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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological/Vaccine: therapeutic autologous dendritic cells. | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological/Vaccine
- description
- Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
- interventionNames
- Biological: Biological/Vaccine: therapeutic autologous dendritic cells.
Primary outcomes (5)
- measure
- Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
- timeFrame
- week 4 and month 6 during vaccine therapy
- measure
- Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion
- timeFrame
- months 2 or 3 and 6 during study treatment, and 6 months after study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR * Recurrent disease involving lymph node metastases or soft tissue nodules * Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery) * Planned resection of tumor to establish an autologous tumor cell line * No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease * Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * At least 4 months Hematopoietic: * Hematocrit greater than 25% * Platelet count greater than 100,000/mm3 * No ongoing transfusion requirements * No active blood clotting or bleeding diathesis Hepatic: * Bilirubin no greater than 2.0 mg/dL * Albumin at least 3.0 g/dL * No significant hepatic dysfunction Renal: * Creatinine no greater than 2.0 mg/dL * No significant renal dysfunction Cardiovascular: * No underlying cardiac disease associated with New York Heart Association class III or IV heart function * No unstable angina related to atherosclerotic cardiovascular disease Other: * No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer * No active infection * No other active medical condition that could be eminently life threatening * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Other prior putative vaccines allowed * Recovered from prior biologic therapy * No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36% Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent corticosteroids Radiotherapy: * At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * Concurrent bisphosphonates allowed for patients with lytic bone metastases * No concurrent digoxin or other medications designed to improve cardiac output * No other concurrent anticancer therapy or investigational therapy
References
Publications (0)
Data not yet available