Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (DCVax-L EAP)

An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients With Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221

The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.

Study Overview

• Status: Available
• Conditions: Glioblastoma Multiforme; GBM
• Intervention / Treatment: Biological: DCVax-L

Detailed Description

Patients who are being screened under protocol 020221 who are not eligible for enrollment due to a) evidence of disease progression or pseudo-progression post chemo-radiation or b) insufficient (<5 doses) vaccine manufactured, and for whom the DCVax-L treatment was manufactured and released are eligible for this study.

Treatment Schedule:

Open label vaccine injections will be give per the associated 020221 protocol. Injections will be given at days 0, 10, 20, and at months 2, 4, 8, 12, 18, 24 and 30. There are no therapeutic restrictions, but guidelines for drug administration are recommended as per the 020221 protocol.

Data collected includes vaccine administration information, and any vaccine related adverse event. Patient MRIs will be collected centrally for future review. Patients will be followed for disease progression and survival.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Available
      • University of Arkansas for Medical Sciences
  • California
    • Los Angeles, California, United States, 90095
      • Available
      • UCLA Medical Center
    • Newport Beach, California, United States, 92663
      • Available
      • Hoag Memorial Hospital
    • Orange, California, United States, 92868
      • Available
      • St. Joseph Hospital of Orange
    • Orange, California, United States, 92868
      • Available
      • University of California, Irvine Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Available
      • University Of Colorado Cancer Center
    • Englewood, Colorado, United States, 80113
      • Available
      • Colorado Neurological Institute
  • Florida
    • Gainesville, Florida, United States, 32611
      • Available
      • University of Florida
    • Hollywood, Florida, United States, 33021
      • Available
      • Memorial Healthcare System Memorial Cancer Institute
  • Illinois
    • Warrenville, Illinois, United States, 60555
      • Available
      • Cadence Cancer Center at Warrenville
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Available
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Available
      • Spectrum Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Available
      • John Nasseff Neuroscience Institute - Abott Northwestern Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Available
      • Saint Luke's Hospital of Kansas City
    • St. Louis, Missouri, United States, 63110
      • Available
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Available
      • John Theurer Cancer Center at Hackensack University Medical Center
    • Trenton, New Jersey, United States, 08638
      • Available
      • Capital Health
  • New York
    • Manhasset, New York, United States, 11030
      • Available
      • North Shore University Hospital
    • New York, New York, United States, 10032
      • Available
      • Columbia University Medical Center Neurological Institute of New York
    • Stony Brook, New York, United States, 11794
      • Available
      • Stony Brook University Hospital
  • Ohio
    • Columbus, Ohio, United States, 043210
      • Available
      • Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Available
      • University of Oklahoma Health Science Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Available
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Available
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Available
      • Saint Thomas Research Institute
  • Washington
    • Seattle, Washington, United States, 98122
      • Available
      • Swedish Neuroscience Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 23215
      • Available
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Screen-Fail for protocol 020221 due to either:

   • Radiographic evidence of disease progression or pseudoprogression at the Baseline visit under protocol 020221, as determined by central imaging review, OR
   • Insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses).
2. Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales).
3. Patients may have received steroid therapy as part of their primary treatment. Steroid treatment should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone qd at least 7 days prior to the first immunization .
4. DCVax-L product manufactured and released.

Exclusion Criteria:

1. Active uncontrolled infection, or acute infection requiring antibiotic or antifungal therapy. Antibiotic and antifungal therapy should be completed approximately 7 days prior to the first immunization.
2. Fever ≥101.5oF. If considered possibly transient, retesting is allowed.
3. Unstable or severe intercurrent medical conditions.
4. Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm). 020221 Baseline lab results and or local lab results are acceptable.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Northwest Biotherapeutics

Study record dates

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: GBM; Brain tumor; glioblastoma; Brain tumor WHO grade IV
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 0202EA