Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer

NCT02170389 | Terminated Results DMC

• 4 other identifiers: I 250113NCI-2014-01254AGS-003-012P30CA016056
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies vaccine therapy before surgery in treating patients with kidney cancer that 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.

Conditions

Recurrent Renal Cell Carcinoma; Stage I Renal Cell Cancer; Stage II Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Immune Marker Expression Levels

  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.

  Baseline to up to 30 days post-nephrectomy

Secondary Outcomes (1)

• Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0

  Up to 30 days

Study Arms (1)

Treatment (AGS-003 immunotherapy, nephrectomy)

EXPERIMENTAL

Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 ID once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.

Other: Laboratory Biomarker Analysis; Procedure: Nephrectomy; Biological: Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (AGS-003 immunotherapy, nephrectomy)

Nephrectomy PROCEDURE

Undergo partial or radical nephrectomy

Treatment (AGS-003 immunotherapy, nephrectomy)

Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003 BIOLOGICAL

Given ID

Also known as: AGS-003

Treatment (AGS-003 immunotherapy, nephrectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Known 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nephrectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

Adrienne.Groman@RoswellPark.org

716-845-2300

Study Officials

• Dr. med.Thomas Schwaab, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: October 14, 2014
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: July 7, 2020
• Results First Posted: January 6, 2020

Record last verified: 2020-07

Locations

US (1)