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Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400917
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

Tracking Information
First Submitted Date  ICMJE January 10, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE June 20, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2018)
Primary Efficacy Endpoint: Overall Survival [ Time Frame: 3 years ]
Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
Official Title  ICMJE Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma
Brief Summary This is a single-arm, open-label phase II clinical trial in which approximately 55 patients with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1).
Detailed Description

This is a single-arm, open-label phase II clinical trial in which approximately 55 patients will be enrolled with the intent to receive AV-GBM-1. Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

The primary endpoint of this trial is overall survival (OS), death from any cause measured from the date of study enrollment for treatment with AV-GBM-1. Secondary endpoints will include (1) PFS measured from date of enrollment, (2) OS/PFS measured from date of diagnosis and (3) OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection. Tertiary endpoints will include (1) OS/PFS from date of first injection and (2) OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.

Patient Population: Patients 18 years or older with newly diagnosed glioblastoma [World Health Organization (WHO) Grade IV glioma, Grade IV anaplastic astrocytoma, glioblastoma or gliosarcoma, glioblastoma multiforme (GBM)] who have recovered from surgery, for whom an autologous tumor cell culture and leukapheresis product are available, who have a KPS of > 70, and who are about to begin concurrent CT/RT.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Newly Diagnosed Glioblastoma
Intervention  ICMJE Biological: AV-GBM-1
Investigational treatment with AV-GBM-1
Study Arms  ICMJE Experimental: AV-GBM-1
Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells. AV-GBM-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.
Intervention: Biological: AV-GBM-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2018)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Karnofsky Performance Score of 70-100%
  • Histology confirmed to be GBM (Grade IV WHO, glioblastoma, gliosarcoma)
  • Successful establishment of an autologous cancer cell line by AIVITA Biomedical, Inc.
  • Collection of a satisfactory leukapheresis product
  • About to begin concurrent CT/RT
  • Given written informed consent to participate in the study

Exclusion Criteria:

  • Known to have active hepatitis B or C or HIV
  • Karnofsky Performance Score of < 70%
  • Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
  • Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than GBM
  • Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
  • Known autoimmune disease, immunodeficiency, or disease process that involves the chronic use of immunosuppressive therapy.
  • Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment.
  • Known hypersensitivity to GM-CSF
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03400917
Other Study ID Numbers  ICMJE CL-GBM-P01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aivita Biomedical, Inc.
Study Sponsor  ICMJE Aivita Biomedical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert O Dillman, MD Aivita Biomedical, Inc.
PRS Account Aivita Biomedical, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP