Clinical trial · Interventional
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
NCT00082459CI-TRIAL-00007984terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor.
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 |
|---|---|---|---|
| autologous human tumor-derived HSPPC-96 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor * No previous therapy for metastatic renal cell carcinoma * Measurable disease (RECIST criteria) * Primary tumor greater than or equal to 7cm on CT or MRI * ECOG performance status 0-1 * At least 18 years old * Life expectancy \> 3 months * Adequate cardiac function (NYHA I-II) * Not pregnant * Provide written informed consent * Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features) * Planned complete nephrectomy Exclusion Criteria: * History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A * Other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin) * Embolization of the renal artery prior to nephrectomy * Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator
References
Publications (0)
Data not yet available
No reference posted for this study.