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

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.

Key facts

Study ID

NCT00678119

Run by

Argos Therapeutics

People needed

25

Starts

2008-01-01

Expected to finish

2012-05-01

Last updated by the study team

2013-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States
• UCLA — Los Angeles, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• The Indiana University Cancer Center — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
• Carolina's Medical Center / Blumenthal Cancer Center — Charlotte, North Carolina, United States
• Barrett Cancer — Cincinnati, Ohio, United States
• CORTPA — Dallas, Texas, United States
• Urology of Virginia-Sentara Medical Group — Norfolk, Virginia, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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