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

Stopped early · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01147536

Run by

Agenus Inc.

People needed

12

Starts

2010-01-01

Expected to finish

2012-06-01

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Community Care Physicians — Albany, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Pavillion de Recherche de Hotel Dieu — Québec, Canada

Full record on ClinicalTrials.gov

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