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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

autologous human tumor-derived HSPPC-96

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney Cancer, Renal, Tumor, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00082459

First Posted

May 10, 2004

Last Updated

September 6, 2012

Sponsor

Agenus Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00082459

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

July 2002 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Agenus Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

Keywords

Kidney Cancer, Renal, Tumor, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

autologous human tumor-derived HSPPC-96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Facility Information:

City

Houston

State/Province

Texas

Country

United States

Renal Cell Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial