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
1 other identifier
interventional
600
2 countries
7
Brief Summary
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 autologous HSPPC-96 or no adjuvant treatment. All patients will undergo complete surgical removal of their tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2005
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 2, 2005
CompletedFirst Posted
Study publicly available on registry
August 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedSeptember 7, 2012
September 1, 2012
10 months
August 2, 2005
September 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
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)
To further characterize the safety profile of HSPPC-96
Interventions
Eligibility Criteria
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agenus Inc.lead
Study Sites (7)
Unknown Facility
San Francisco, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
South Burlington, Vermont, United States
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2005
First Posted
August 3, 2005
Study Start
May 1, 2005
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
September 7, 2012
Record last verified: 2012-09