Trial record 3 of 10 for:    AGS-003

Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT02170389
First received: June 19, 2014
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

This pilot clinical trial studies vaccine therapy before surgery in treating patients with kidney cancer has not spread to nearby lymph nodes or to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells when they are infused back into the body.


Condition Intervention
Recurrent Renal Cell Cancer
Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Biological: renal cell carcinoma/CD40L RNA-transfected autologous dendritic cell vaccine AGS-003
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant AGS-003 Immunotherapy in Patients With Localized Kidney Cancer <pT2

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Change in immune marker expression levels [ Time Frame: Baseline to up to 30 days post-nephrectomy ] [ Designated as safety issue: No ]

    The time component will be modeled as a three-level classification factor. The full model for the effects of time will be fit using linear mixed model methods. The model will include a random patient effect and 5 fixed effects for time and the interactions. The presence of any time effect will be assessed with full-reduced model type 3 test. If the omnibus test is statistically significant at the p < 0.05 level, then three pairwise time-point comparisons will be conducted.

    Expression measurements may be transformed to satisfy modeling assumptions.



Secondary Outcome Measures:
  • Adverse event rates as graded by the Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Summarized in all patients who received AGS-003. These rates will be described as the proportion of patients with the event, by grade, and supported with exact 95% confidence intervals.


Estimated Enrollment: 10
Study Start Date: October 2014
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (AGS-003 immunotherapy, nephrectomy)
Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID on weeks 6, 7, 8, 9, and 10 in the absence of disease progression or unacceptable toxicity. Patients then undergo nephrectomy on week 12.
Biological: renal cell carcinoma/CD40L RNA-transfected autologous dendritic cell vaccine AGS-003
Given ID
Other Name: AGS-003
Procedure: therapeutic conventional surgery
Undergo partial or radical nephrectomy
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the immune-modulatory systemic and intratumoral effects of AGS-003 (renal cell carcinoma/cluster of differentiation [CD]40L ribonucleic acid [RNA]-transfected autologous dendritic cell vaccine AGS-003) as neoadjuvant treatment in patients with localized renal cell carcinoma.

SECONDARY OBJECTIVES:

I. To assess the feasibility that total tumor RNA processing-related activities meet specifications for AGS-003 manufacturing utilizing a core needle biopsy procedure for tumor harvesting prior to nephrectomy.

OUTLINE:

Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 intradermally (ID) on weeks 6, 7, 8, 9, and 10 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 12.

After completion of study treatment, patients are followed up at 1 month.

  Eligibility

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

Inclusion Criteria:

  • Have localized non-metastatic renal cell carcinoma (RCC) (< pT2, NO, MO), as per the American Joint Committee on Cancer (AJCC) seventh (7th) edition criteria
  • Must be surgical candidates as deemed fit by surgeon
  • Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
  • Willingness to undergo leukapheresis and biopsy procedures for the autologous components (peripheral blood mononuclear cells, plasma and fresh tumor specimen) required for manufacture of AGS-003
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (e.g., shortness of breath, fatigue, orthopnea, paroxysmal nocturnal dyspnea), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Radiation to primary tumor prior to enrollment in this study
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Active autoimmune disease or condition requiring chronic immunosuppressive therapy (e.g., rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)

    • NOTE: abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary
  • Clinically significant infections, including human immunodeficiency virus (HIV) and active hepatitis B or C
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk by participating in this study)
  • Chronic use of systemic corticosteroids (i.e., >= 10 mg/day prednisone or equivalent)
  • Received an investigational agent within 30 days prior to enrollment
  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: NCT02170389

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Thomas Schwaab         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Thomas Schwaab Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT02170389     History of Changes
Other Study ID Numbers: I 250113, NCI-2014-01254, AGS-003-012, I 250113, P30CA016056
Study First Received: June 19, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014