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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00678119
Other study ID # AGS-003-006
Secondary ID
Status Completed
Phase Phase 2
First received May 14, 2008
Last updated July 11, 2013
Start date January 2008
Est. completion date May 2012

Study information

Verified date July 2013
Source Argos Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
AGS-003
Dendritic cell Immunotherapeutic
Drug:
Sunitinib
An approved drug for the treatment of RCC

Locations

Country Name City State
Canada Jewish General Hospital Montreal Quebec
Canada Princess Margaret Hospital Toronto Ontario
United States Emory University Atlanta Georgia
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 The Urology Center of Colorado Denver Colorado
United States City of Hope Duarte California
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 UCLA Los Angeles California
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Urology of Virginia-Sentara Medical Group Norfolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Argos Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks No
Secondary The monitoring of clinical activity, immune response and safety across multiple doses. 24 weeks Yes
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