Clinical trial NCT01147536: Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Official title: A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage) for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Primary outcomes:
measure: Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
timeFrame: 6-7 weeks post surgery up to Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Community Care Physicians
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Quebec
country: Canada
facility: Pavillion de Recherche de Hotel Dieu
Study officials:
affiliation: Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec
name: Louis Lacombe, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas MD Anderson Cancer Center
name: Christopher G Wood, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Care Physicians, PC; The Urological Institute of Northeastern New York
name: Ronald P Kaufman, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: