Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

NCT ID: NCT00082459

Last Updated: 2012-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2005-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

autologous human tumor-derived HSPPC-96

Intervention Type: BIOLOGICAL

Eligibility 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-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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agenus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Houston, Texas, United States

Countries

United States

Other Identifiers

C-100-23

Identifier Type: -

Identifier Source: org_study_id