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

Sponsored by:	Antigenics
Information provided by:	Antigenics
ClinicalTrials.gov Identifier:	NCT00082459

Purpose

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.

Condition	Intervention	Phase
Renal Cell Carcinoma	Biological: autologous human tumor-derived HSPPC-96	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Oncophage

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

Further study details as provided by Antigenics:

Estimated Enrollment:	40
Study Start Date:	July 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082459

Locations

United States, Texas

Houston, Texas, United States

Sponsors and Collaborators

Antigenics

More Information

Click here for more information regarding HSPPC-96 at Antigenics' website. This link exits the ClinicalTrials.gov site

Study ID Numbers:	C-100-23
Study First Received:	May 10, 2004
Last Updated:	March 7, 2006
ClinicalTrials.gov Identifier:	NCT00082459
Health Authority:	United States: Food and Drug Administration

Keywords provided by Antigenics:

Kidney Cancer
Renal
Tumor
Immunotherapy

Study placed in the following topic categories:

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases

Kidney cancer
Urologic Neoplasms
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009