Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
Stopped early · Phase 2
Conditions studied: Renal Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT00082459
- Run by
- Agenus Inc.
- People needed
- 40
- Starts
- 2002-07-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2012-09-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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