Kidney Cancer Clinical Trial

Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence

Summary

The primary objective of the study is to determine whether participants exhibit a measurable immune response after multiple administrations of HSPPC-96 (heat shock protein-peptide complex 96), as assessed by enzyme linked immunosorbent spot (ELISPOT) assay.

View Full Description

Full Description

The study consists of two parts: Part 1 with Part 1a (Assessment of Immune Variation) and Part 1b (Assay Standardization), and Part 2 (Immune Monitoring Study). The study was terminated early with 12 participants enrolled only in Part 1a and Part 1b. Part 2 of the study involved randomization after 8 doses of HSSPC-96. After the 8 doses of HSSPC-96 administered in Part 2, the participants were to be randomized to the treatment extension arm or the placebo extension arm. There were no participants enrolled in Part 2 since the study was terminated early. Therefore, no randomization occurred in the conduct of this study and only a single arm was enrolled.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmation of histological diagnosis of renal cell carcinoma (RCC) with evidence of >= 25% clear cell carcinoma
American joint committee on cancer tumor/node/metastasis tumor stage at intermediate risk for recurrence
At least 8 doses of vaccine available from participant's tumor
Life expectancy of at least 3 months
Eastern cooperative oncology group performance status of 0 or 1
Cardiovascular disease status of new york heart association class less than 2
Adequate hematopoietic, renal and hepatic function
Negative serology tests for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV-1), hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (anti-HCV-Ab)
Females must have negative pregnancy test

Exclusion Criteria:

Evidence of metastatic or residual RCC
Documented radiological enlarged lymph nodes
Females who are pregnant or breastfeeding
Use of any other investigational product from 4 weeks post-surgery
Splenectomy performed during nephrectomy

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

12

Study ID:

NCT01147536

Recruitment Status:

Terminated

Sponsor:

Agenus Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Community Care Physicians
Albany New York, 12208, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Pavillion de Recherche de Hotel Dieu
Quebec , G1R 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

12

Study ID:

NCT01147536

Recruitment Status:

Terminated

Sponsor:


Agenus Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider