Renal cell carcinoma. MedDRA version: 9.1 Level: LLT Classification code 10038395 Term: Renal carcinoma
Conditions
Interventions
Product Name: Oncophage
Product Code: HSPPC-96
Pharmaceutical Form: Solution for injection
CAS Number: 492448-75-6
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentra
Sponsors
Antigenics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible, patients must have: 1.Participated in the Antigenics C-100-12 (Part I) protocol and terminated the study with the last survival status reported as “alive” and due to “administrative study closure”. 2.Signed an informed consent to participate in the C-100-27 Survival Follow-up protocol, and be willing to receive contact from a representative from the protocol investigative study centers and/or any subsequently identified co-investigator sites where patients consent to continued survival follow-up and/or a member from a company designated by the Sponsor every 6 months if no disease recurrence and every 3 months if disease has recurred. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The study has no exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the INSPIRE study is to evaluate the overall survival of patients who participated in the Antigenics C-100-12 (Part I) study.;Secondary Objective: To describe investigator-reported disease recurrence for patients who, at time of study closure of Antigenics C-100-12 (part I) study, were raported by the investigator as being disease-free.;Primary end point(s): - The duration of survival, reported as date of death. Date of death is to include, at minimum, the month and year of death. - If available, additional endpoint data for cause of death will be reported as progression of renal cell carcinoma, other disease or unknown. - If available, endpoint data for disease recurrence will be reported as confirmed disease recurrence, absent disease recurrence or unknown. In addition, the date of recurrence will be reported, per the investigator, as the earliest date of radiologic or nonradiologic evaluation that identified the lesion subsequently determined to be recurrence of renal cell carcinoma. | — |
Countries
Austria, Germany, Spain, Sweden
Outcome results
None listed