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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Oncophage

U.S. FDA Resources

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

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00082459 History of Changes
Other Study ID Numbers:	C-100-23
Study First Received:	May 10, 2004
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Antigenics:

Kidney Cancer
Renal
Tumor
Immunotherapy

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma

Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012