- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126178
Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer
A Multi-Center, Randomized, Phase 3 Study of Adjuvant Oncophage® Versus Observation in Patients With High Risk After Surgical Treatment for Renal Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an international, open label, randomized Phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.
The primary objective of the study is to determine whether patients who receive adjuvant autologous HSPPC-96 (treatment group) after surgical resection of locally advanced renal cell carcinoma have improved recurrence-free survival as compared to patients who are not receiving adjuvant treatment (observation group). Eligible patients will have a 50% chance of receiving adjuvant treatment with HSPPC-96. Patients in the treatment arm of the trial will receive the vaccine once a week for 4 weeks, and then every other week until vaccine depletion or disease recurrence. Both groups of patients will be followed regularly for assessment of their disease status.
HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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British Columbia
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Victoria, British Columbia, Canada
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Ontario
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Toronto, Ontario, Canada
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California
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San Francisco, California, United States
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Stanford, California, United States
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New Jersey
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Hackensack, New Jersey, United States
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Texas
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San Antonio, Texas, United States
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Vermont
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South Burlington, Vermont, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
This does not represent the full set of inclusion/exclusion criteria
Inclusion Criteria:
- Patients must have primary-intact resectable renal cell cancer, without distant metastasis and be scheduled to have surgery with curative intent
- Tumor size > 5 cm OR macroscopic nodes OR vena cava thrombus by radiologic evaluation
- At least 18 years old
- Signed informed consent
Exclusion Criteria:
- Prior surgery, chemo-, hormonal-, immuno-, or radiotherapy for kidney cancer
- History of other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin
- Current malignancies of any type in other sites
- No active uncontrolled infection, other serious medical illnesses, or splenectomy
- History of primary or secondary immunodeficiencies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine whether patients randomized to receive adjuvant HSPPC-96 (treatment) after surgical resection of the kidney cancer have improved recurrence-free survival as compared to patients who did not receive adjuvant treatment (observation)
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Secondary Outcome Measures
Outcome Measure |
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To determine whether patients randomized to receive adjuvant HSPPC-96 have improved overall survival as compared to patients in the observation group (without adjuvant treatment)
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To further characterize the safety profile of HSPPC-96
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-100-12 Part 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Cancer
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnKidney/Urinary Cancer
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PfizerCompletedKidney Cancer | Kidney Neoplasms | Renal Cell Carcinoma | Renal Cancer | Renal Cell Cancer | Cancer of the Kidney | Cancer of KidneyFinland
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Tianjin Medical University Second HospitalRecruiting
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Cedars-Sinai Medical CenterRecruitingProstate Cancer Stage II | Prostate Cancer Stage I | Bladder Cancer Stage II | Kidney Cancer Stage IUnited States
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Tianjin Medical University Second HospitalRecruiting
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Dana-Farber Cancer InstituteCompletedKidney Cancer | Prostate Cancer | Genitourinary CancerUnited States
-
Intuitive SurgicalCompleted
-
University of Texas Southwestern Medical CenterCompletedKidney Cancer | Kidney Cancer Metastatic | Kidney Cancer, Stage IVUnited States
-
Yale UniversityCompleted
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Stanford UniversityNational Cancer Institute (NCI)WithdrawnProstate Cancer | Bladder Cancer | Kidney Tumor
Clinical Trials on HSPPC-96
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Agenus Inc.TerminatedRenal Cell CarcinomaUnited States, Canada
-
Agenus Inc.CompletedLung Cancer | Non-Small-Cell Lung Carcinoma | Pulmonary CancerUnited Kingdom
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Agenus Inc.CompletedRenal Cell CarcinomaUnited States, France, Poland, United Kingdom, Spain, Israel, Canada, Belgium, Norway, Sweden, Austria
-
Agenus Inc.CompletedLymphoma, Follicular | Lymphoma, Small LymphocyticUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoNorthwestern UniversityTerminatedGlioblastoma Multiforme | Ependymoma | Anaplastic Ependymoma | Astrocytoma, Grade III | Clear Cell EpendymomaUnited States
-
Agenus Inc.Terminated
-
Agenus Inc.CompletedMalignant MelanomaUnited States, Australia, Poland, Ukraine, United Kingdom, Russian Federation, Hungary, Italy, Sweden
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National Cancer Institute (NCI)Completed
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Rabih SaidAgenus Inc.Withdrawn
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Cure&Sure Biotech Co., LTDBeijing Tiantan Hospital; Shenzhen Second People's HospitalRecruiting