NCT00272649

Brief Summary

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

6.1 years

First QC Date

January 6, 2006

Last Update Submit

March 6, 2013

Conditions

Renal Cell Carcinoma

Keywords

Kidney cancerRenal cancer

Outcome Measures

Primary Outcomes (1)

  • 1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.

    24 weeks

Secondary Outcomes (1)

  • Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression

    24 weeks plus follow-up

Study Arms (1)

Single Arm

EXPERIMENTAL

Single Arm study

Biological: AGS-003

Interventions

AGS-003BIOLOGICAL

Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

Also known as: Dendritic Cell Immunotherapeutic
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a new diagnosis of metastatic renal cell carcinoma;
  • Measurable disease
  • Must be at least 18 years or older;
  • Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
  • ECOG of 0 or 1;
  • Free of brain metastases by CT or MRI;
  • Normal renal function in contralateral kidney;
  • Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
  • Clinically acceptable screening results.
  • No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
  • No active autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

UCLA Kidney Cancer Program

Los Angeles, California, 90095-7207, United States

Location

Univ. of Colorado Health Science Center - Division of Medical Oncology

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

The Indiana University Cancer Center/IUPUI

Indianapolis, Indiana, 46202, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Carolinas Medical Center/Blumenthal Cancer Center

Charlotte, North Carolina, 28204, United States

Location

Earle A. Chiles Research Institute

Portland, Oregon, 97213-2933, United States

Location

Princess Margaret Hospital

Toronto, Ontario, MG5 2M9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Terry Chew, MD

    Argos Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

January 1, 2006

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

CA(2)US(8)