or
forgot password

A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

Thank you

Trial Information

A Randomized Phase II Study Investigating the Route of Administration of Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

C-100-23

NCT ID:

NCT00082459

Start Date:

July 2002

Completion Date:

December 2005

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney Cancer
  • Renal
  • Tumor
  • Immunotherapy
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
Austin, Texas  78705