Status:
COMPLETED
Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment
Lead Sponsor:
Argos Therapeutics
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.
Detailed Description
The purpose of this study is to investigate an anticancer immunotherapeutic, AGS-003, when used in combination with sunitinib (the treatment regimen) in a single-stage, Phase II design in subjects wit...
Eligibility Criteria
Inclusion
- Male and female subjects ≥18 years of age with newly diagnosed advanced stage RCC will be eligible for inclusion in this study if all of the following criteria apply:
- Newly diagnosed advanced stage RCC.
- Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
- Measurable disease.
- Candidate for sunitinib treatment as labeled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
- No brain metastases detected by MRI.
- Normal renal function in the contralateral kidney.
- Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
- Use of appropriate birth control methods for the duration of the study for women of childbearing potential and men with female partners of childbearing potential.
- Clinically acceptable Screening results according to the following specific limits:
- Adequate hematologic function.
- Adequate renal and hepatic function.
- Adequate coagulation function.
- Normal serum calcium.
- Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
- Voluntary informed consent given to participate in the study.
Exclusion
- Subjects will NOT be eligible for inclusion in this study if any of the following criteria apply:
- Nephrectomy for RCC therapy is required.
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
- Uncontrolled hypertension.
- Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
- Prior systemic therapy for advanced stage RCC.
- Active autoimmune disease.
- Prior history of malignancy other than RCC within the preceding 5 years, except for adequately treated cervical cancer or non-melanoma skin cancer.
- Use of prohibited prescription or prohibited non-prescription drugs during 2 months prior to entry into the study.
- Active, acute, or chronic clinically significant infections.
- Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.
- Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional biopsy/metastasectomy.
- History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring management.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Body weight less than 30 kg.
- Pregnancy or lactation.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00678119
Start Date
January 1 2008
End Date
May 1 2012
Last Update
July 15 2013
Active Locations (14)
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1
City of Hope
Duarte, California, United States, 91010
2
UCLA
Los Angeles, California, United States, 90095
3
The Urology Center of Colorado
Denver, Colorado, United States, 80211
4
Emory University
Atlanta, Georgia, United States, 30322