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

Glioblastoma Multiforme Clinical Trial

— DCVax-L EAP  

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02146066
• Other study ID #: 0202EA
• Status: Available
• Phase: N/A
• First received: May 21, 2014
• Last updated: February 25, 2016

Study information

• Verified date: February 2016
• Source: Northwest Biotherapeutics
• Contact: Marnix Bosch, MBA PhD
• Phone: 240 497 9022
• Email: marnix[@]nwbio.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• GBM
• Glioblastoma
• Glioblastoma Multiforme

Intervention

Biological:
• DCVax-L
Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Colorado Neurological Institute	Englewood	Colorado
United States	University of Florida	Gainesville	Florida
United States	Spectrum Health	Grand Rapids	Michigan
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Memorial Healthcare System Memorial Cancer Institute	Hollywood	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	UCLA Medical Center	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	John Nasseff Neuroscience Institute - Abott Northwestern Hospital	Minneapolis	Minnesota
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center Neurological Institute of New York	New York	New York
United States	Hoag Memorial Hospital	Newport Beach	California
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	St. Joseph Hospital of Orange	Orange	California
United States	University of California, Irvine Medical Center	Orange	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Capital Health	Trenton	New Jersey
United States	Cadence Cancer Center at Warrenville	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwest Biotherapeutics

Country where clinical trial is conducted

United States,