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
NCT ID: NCT00678119
Last Updated: 2013-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2008-01-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1: AGS-003+sunitinib
Single arm study AGS-003 plus sunitinib
AGS-003
Dendritic cell Immunotherapeutic
Sunitinib
An approved drug for the treatment of RCC
Interventions
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AGS-003
Dendritic cell Immunotherapeutic
Sunitinib
An approved drug for the treatment of RCC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Newly diagnosed advanced stage RCC.
2. Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
3. Measurable disease.
4. Candidate for sunitinib treatment as labeled.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
7. No brain metastases detected by MRI.
8. Normal renal function in the contralateral kidney.
9. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
10. 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.
11. Clinically acceptable Screening results according to the following specific limits:
* Adequate hematologic function.
* Adequate renal and hepatic function.
* Adequate coagulation function.
12. Normal serum calcium.
13. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
14. Voluntary informed consent given to participate in the study.
Exclusion Criteria
1. Nephrectomy for RCC therapy is required.
2. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
3. Uncontrolled hypertension.
4. Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
5. Prior systemic therapy for advanced stage RCC.
6. Active autoimmune disease.
7. Prior history of malignancy other than RCC within the preceding 5 years, except for adequately treated cervical cancer or non-melanoma skin cancer.
8. Use of prohibited prescription or prohibited non-prescription drugs during 2 months prior to entry into the study.
9. Active, acute, or chronic clinically significant infections.
10. Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.
11. Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional biopsy/metastasectomy.
12. History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring management.
13. Known hypersensitivity to dimethyl sulfoxide (DMSO).
14. Body weight less than 30 kg.
15. Pregnancy or lactation.
18 Years
ALL
No
Sponsors
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Argos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Miesowicz
Role: STUDY_DIRECTOR
Argos Therapeutics
Locations
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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
Countries
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References
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Amin A, Dudek AZ, Logan TF, Lance RS, Holzbeierlein JM, Knox JJ, Master VA, Pal SK, Miller WH Jr, Karsh LI, Tcherepanova IY, DeBenedette MA, Williams WL, Plessinger DC, Nicolette CA, Figlin RA. Survival with AGS-003, an autologous dendritic cell-based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results. J Immunother Cancer. 2015 Apr 21;3:14. doi: 10.1186/s40425-015-0055-3. eCollection 2015.
Related Links
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Argos Therapeutics Website
Kidney Cancer Association
Other Identifiers
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AGS-003-006
Identifier Type: -
Identifier Source: org_study_id
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