Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
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ClinicalTrials.gov Identifier: NCT01147536 |
Recruitment Status :
Terminated
(Sponsor's business decision)
First Posted : June 22, 2010
Results First Posted : June 3, 2021
Last Update Posted : June 3, 2021
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Condition or disease | Intervention/treatment | Phase |
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Renal Cell Carcinoma | Biological: HSPPC-96 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | January 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: HSPPC-96 Vaccine
Participants will receive up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants will remain untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.
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Biological: HSPPC-96
Other Names:
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- Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay [ Time Frame: 6-7 weeks post surgery up to Week 14 ]The ELISPOT assay was not developed for this study and no immunogenicity data are available.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147536
United States, New York | |
Community Care Physicians | |
Albany, New York, United States, 12208 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Canada | |
Pavillion de Recherche de Hotel Dieu | |
Quebec, Canada, G1R 2J6 |
Principal Investigator: | Louis Lacombe, MD, FRCSC | Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec | |
Principal Investigator: | Christopher G Wood, MD, FACS | The University of Texas MD Anderson Cancer Center | |
Principal Investigator: | Ronald P Kaufman, MD, FACS | Community Care Physicians, PC; The Urological Institute of Northeastern New York |
Responsible Party: | Agenus Inc. |
ClinicalTrials.gov Identifier: | NCT01147536 |
Obsolete Identifiers: | NCT01073254 |
Other Study ID Numbers: |
C-100-38 |
First Posted: | June 22, 2010 Key Record Dates |
Results First Posted: | June 3, 2021 |
Last Update Posted: | June 3, 2021 |
Last Verified: | May 2021 |
Carcinoma Carcinoma, Renal Cell Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes |
Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |