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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 3 Locations for this study
Albany New York, 12208, United States
Houston Texas, 77030, United States
Quebec , G1R 2, Canada
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.