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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02146066
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwest Biotherapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Available
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

GBM, Glioblastoma Multiforme
Additional 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock 4119403, Arkansas 4099753

Status

Available

Address

University of Arkansas for Medical Sciences

Little Rock 4119403, Arkansas 4099753, 72205

Site Contact

Shana Fetters

[email protected]

501-686-8274

UCLA Medical Center, Los Angeles 5368361, California 5332921

Status

Available

Address

UCLA Medical Center

Los Angeles 5368361, California 5332921, 90095

Site Contact

Diana Moughon

[email protected]

310-794-4223

Hoag Memorial Hospital, Newport Beach 5376890, California 5332921

Status

Available

Address

Hoag Memorial Hospital

Newport Beach 5376890, California 5332921, 92663

Site Contact

Robin Bogardus

[email protected]

949-764-4624 #57019

St. Joseph Hospital of Orange, Orange 5379513, California 5332921

Status

Available

Address

St. Joseph Hospital of Orange

Orange 5379513, California 5332921, 92868

Site Contact

Martha French

[email protected]

714-734-6200 #40838

Orange 5379513, California 5332921

Status

Available

Address

University of California, Irvine Medical Center

Orange 5379513, California 5332921, 92868

Site Contact

Jinah Chung

[email protected]

714-456-8442

University of Colorado Cancer Center, Aurora 5412347, Colorado 5417618

Status

Available

Address

University of Colorado Cancer Center

Aurora 5412347, Colorado 5417618, 80045

Site Contact

Monica Robischon

[email protected]

720-848-0661

Colorado Neurological Institute, Englewood 5421250, Colorado 5417618

Status

Available

Address

Colorado Neurological Institute

Englewood 5421250, Colorado 5417618, 80113

Site Contact

Alicia Novak

[email protected]

303-806-7423

University of Florida, Gainesville 4156404, Florida 4155751

Status

Available

Address

University of Florida

Gainesville 4156404, Florida 4155751, 32611

Site Contact

Whitney McNeal

[email protected]

352-273-7774

Hollywood 4158928, Florida 4155751

Status

Available

Address

Memorial Healthcare System Memorial Cancer Institute

Hollywood 4158928, Florida 4155751, 33021

Site Contact

Nithya Sundararaman, MA, MS, MBA, CCRP

[email protected]

+1-954-265-1846

Cadence Cancer Center at Warrenville, Warrenville 4915525, Illinois 4896861

Status

Available

Address

Cadence Cancer Center at Warrenville

Warrenville 4915525, Illinois 4896861, 60555

Site Contact

Claudia Fredian

[email protected]

630-352-5261

Beth Israel Deaconess Medical Center, Boston 4930956, Massachusetts 6254926

Status

Available

Address

Beth Israel Deaconess Medical Center

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

Emma Breault

[email protected]

617-667-5984

Spectrum Health, Grand Rapids 4994358, Michigan 5001836

Status

Available

Address

Spectrum Health

Grand Rapids 4994358, Michigan 5001836, 49503

Site Contact

Marianne Morrissey

[email protected]

616-391-1129

Minneapolis 5037649, Minnesota 5037779

Status

Available

Address

John Nasseff Neuroscience Institute - Abott Northwestern Hospital

Minneapolis 5037649, Minnesota 5037779, 55407

Site Contact

Anna Kistner

[email protected]

612-863-9166

Saint Luke's Hospital of Kansas City, Kansas City 4393217, Missouri 4398678

Status

Available

Address

Saint Luke's Hospital of Kansas City

Kansas City 4393217, Missouri 4398678, 64111

Site Contact

Jennifer McIntire

[email protected]

816-932-7985

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

Status

Available

Address

Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63110

Site Contact

Andrew Wegrzyn

[email protected]

314-747-1825

Hackensack 5098706, New Jersey 5101760

Status

Available

Address

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack 5098706, New Jersey 5101760, 07601

Site Contact

Lori Cappello

[email protected]

201-996-5098

Capital Health, Trenton 5105496, New Jersey 5101760

Status

Available

Address

Capital Health

Trenton 5105496, New Jersey 5101760, 08638

Site Contact

Cynthia Lewis-Diaz

[email protected]

609-394-6287

North Shore University Hospital, Manhasset 5125766, New York 5128638

Status

Available

Address

North Shore University Hospital

Manhasset 5125766, New York 5128638, 11030

Site Contact

Louise Purcell

[email protected]

516-941-1263

New York 5128581, New York 5128638

Status

Available

Address

Columbia University Medical Center Neurological Institute of New York

New York 5128581, New York 5128638, 10032

Site Contact

Christina Corpus

[email protected]

212-342-1653

Stony Brook University Hospital, Stony Brook 5139865, New York 5128638

Status

Available

Address

Stony Brook University Hospital

Stony Brook 5139865, New York 5128638, 11794

Site Contact

Susan Fiore, M.S.

[email protected]

631-444-9425

Ohio State University, Columbus 4509177, Ohio 5165418

Status

Available

Address

Ohio State University

Columbus 4509177, Ohio 5165418, 043210

Site Contact

Aubrey Hastings

[email protected]

614-293-8607

Oklahoma City 4544349, Oklahoma 4544379

Status

Available

Address

University of Oklahoma Health Science Center

Oklahoma City 4544349, Oklahoma 4544379, 73104

Site Contact

Stephanie McKnight

[email protected]

405-271-8777

Geisinger Medical Center, Danville 5186327, Pennsylvania 6254927

Status

Available

Address

Geisinger Medical Center

Danville 5186327, Pennsylvania 6254927, 17822

Site Contact

Lynne Belles

[email protected]

570-271-6780

Philadelphia 4560349, Pennsylvania 6254927

Status

Available

Address

Hospital of the University of Pennsylvania

Philadelphia 4560349, Pennsylvania 6254927, 19104

Site Contact

Suzanne Frangos, RN, CNRN

[email protected]

215-285-2885

Saint Thomas Research Institute, Nashville 4644585, Tennessee 4662168

Status

Available

Address

Saint Thomas Research Institute

Nashville 4644585, Tennessee 4662168, 37205

Site Contact

Nancy Grimes, RN

[email protected]

615-222-4356

Swedish Neuroscience Institute, Seattle 5809844, Washington 5815135

Status

Available

Address

Swedish Neuroscience Institute

Seattle 5809844, Washington 5815135, 98122

Site Contact

Nathan Hansen

[email protected]

206-320-3542

Aurora Saint Luke's Medical Center, Milwaukee 5263045, Wisconsin 5279468

Status

Available

Address

Aurora Saint Luke's Medical Center

Milwaukee 5263045, Wisconsin 5279468, 23215

Site Contact

Lynda Yanny

[email protected]

414-649-6685

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