TerminatedPhase 2

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

Stopped: Sponsor's business decision

United States, Canada12 participantsStarted 2010-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay

Timeframe: 6-7 weeks post surgery up to Week 14

Trial details

NCT IDNCT01147536

SponsorAgenus Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-06

Results submitted2021-04-12

View on ClinicalTrials.gov More Renal Cell Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.