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Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma Clinical research trials and Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma. Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma clinical trial. Human subjects often receive the most effective healthcare possible for their Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma  Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma
For Condition: Renal Cell Carcinoma
Status: Recruiting
Sponsor(s): Antigenics ,
Synopsis: 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.
Details: 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. The study is being conducted in Houston, Texas with patients enrolled into one of two treatment arms. The two treatment arms are either subcutaneous injection or intradermal injection, both with HSPPC-96. To be treated with HSPPC-96 patients must undergo surgery to remove the kidney tumor and a portion of this tissue will be sent to Antigenics’ manufacturing facility for processing.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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-biopsed 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
Total Enrollment: 40
Location and Contact Information:
Additional Information:
Study ID Numbers: C-100-23;
Study Start Date: July 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082459
Other Renal Cell Carcinoma Studies:
1. Survival Study Of Oncophage® vs. Observation In Patients with Kidney Cancer
2. BMS 247550 to Treat Kidney Cancer
3. Vaccine Therapy with Tumor Specific Mutated VHL Peptides in Adult Cancer Patients with Renal Cell Carcinoma
4. A research study in patients with renal cancer to determine the safety and effectiveness of a new investigational drug called ABX-EGF.
5. Clinical Manifestations and Molecular Bases of Heritable Urologic Malignant Disorders
Related Studies:
Other Renal Cell Carcinoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma
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