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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082459

Enrollment

Registered

2004-05-12

Start date

2002-07-31

Completion date

2005-12-31

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Kidney Cancer, Renal, Tumor, Immunotherapy

Brief summary

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.

Interventions

BIOLOGICALautologous human tumor-derived HSPPC-96

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026