Summary

for people ages 18-70 (full criteria)
at Orange, California and other locations
study started
Daniela Bota

Description

Summary

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.

Official Title

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

Details

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.

Keywords

GBM Glioblastoma Multiforme Brain tumor glioblastoma Brain tumor WHO grade IV DCVax-L

Eligibility

You can join if…

Open to people ages 18-70

  1. Screen-Fail for protocol 020221 due to either:
  2. Radiographic evidence of disease progression or pseudoprogression at the Baseline visit under protocol 020221, as determined by central imaging review, OR
  3. Insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses).
  4. Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales).
  5. 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 .
  6. DCVax-L product manufactured and released.

You CAN'T join if...

  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.

Locations

  • University of California, Irvine Medical Center
    Orange California 92868 United States
  • Hoag Memorial Hospital
    Newport Beach California 92663 United States
  • St. Joseph Hospital of Orange
    Orange California 92868 United States

Lead Scientist

  • Daniela Bota
    Associate Professor, Neurology. Authored (or co-authored) 56 research publications

Details

Status
not accepting new patients
Start Date
Sponsor
Northwest Biotherapeutics
ID
NCT02146066
Study Type
Expanded Access
Last Updated