Clinical trial · Interventional
RNA-Loaded Dendritic Cell Cancer Vaccine
A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma
NCT00087984CI-TRIAL-00009485completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MB-002 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MB-002-003
- interventionNames
- Biological: MB-002
Primary outcomes (2)
- measure
- To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
- timeFrame
- From registration until disease progression or withdrawal from study
- measure
- To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).
- timeFrame
- From registration until disease progression or withdrawal from study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a new diagnosis of metastatic renal cell carcinoma; * Must be at least 18 years or older; * Have a scheduled unilateral nephrectomy; * ECOG of 0 or 1; * Free of brain metastases by CT or MRI; * Normal renal function in contralateral kidney; * Male or non-pregnant/non-lactating female on appropriate birth control methods while on study; * Clinically acceptable screening results. * No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry; * No active autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.