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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT00678119
First received: May 14, 2008
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Renal Cell Carcinoma
Biological: AGS-003
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination With Sunitinib

Resource links provided by NLM:


Further study details as provided by Argos Therapeutics:

Primary Outcome Measures:
  • Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The monitoring of clinical activity, immune response and safety across multiple doses. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: AGS-003+sunitinib
Single arm study AGS-003 plus sunitinib
Biological: AGS-003
Dendritic cell Immunotherapeutic
Drug: Sunitinib
An approved drug for the treatment of RCC
Other Name: Sutent

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 with previously untreated advanced stage RCC after nephrectomy/excisional biopsy/metastasectomy. AGS-003 is formulated using mature DCs co-electroporated with CD40L IVT RNA and autologous total tumor RNA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  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:

Subjects will NOT be eligible for inclusion in this study if any of the following criteria apply:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678119

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
UCLA
Los Angeles, California, United States, 90095
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
The Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Carolina's Medical Center / Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28204
United States, Ohio
Barrett Cancer
Cincinnati, Ohio, United States, 45267
United States, Texas
CORTPA
Dallas, Texas, United States, 75230
United States, Virginia
Urology of Virginia-Sentara Medical Group
Norfolk, Virginia, United States, 23502
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Argos Therapeutics
Investigators
Study Director: Fred Miesowicz Argos Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT00678119     History of Changes
Other Study ID Numbers: AGS-003-006
Study First Received: May 14, 2008
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Argos Therapeutics:
Kidney cancer
Renal cancer
Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014