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

Sponsor

Argos Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00678119

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Biological: AGS-003 Drug: Sunitinib	Phase 2

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

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Sutent

Arm

Intervention/Treatment

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 Names:

Sutent

Outcome Measures

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. [24 weeks]

Secondary Outcome Measures

The monitoring of clinical activity, immune response and safety across multiple doses. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	The Indiana University Cancer Center	Indianapolis	Indiana	United States	46202
6	University of Iowa	Iowa City	Iowa	United States	52242
7	University of Kansas Hospital	Kansas City	Kansas	United States	66160
8	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
9	Carolina's Medical Center / Blumenthal Cancer Center	Charlotte	North Carolina	United States	28204
10	Barrett Cancer	Cincinnati	Ohio	United States	45267
11	CORTPA	Dallas	Texas	United States	75230
12	Urology of Virginia-Sentara Medical Group	Norfolk	Virginia	United States	23502
13	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G2M9
14	Jewish General Hospital	Montreal	Quebec	Canada	H3T1E2