Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221
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.
Conditions
- GBM
- Glioblastoma Multiforme
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Little Rock, Arkansas 72205
Los Angeles, California 90095
Newport Beach, California 92663
Orange, California 92868
Orange, California 92868
Aurora, Colorado 80045
Englewood, Colorado 80113
Gainesville, Florida 32611
Hollywood, Florida 33021
Warrenville, Illinois 60555
Boston, Massachusetts 02215
Grand Rapids, Michigan 49503
Minneapolis, Minnesota 55407
Kansas City, Missouri 64111
St. Louis, Missouri 63110
Hackensack, New Jersey 07601
Trenton, New Jersey 08638
Manhasset, New York 11030
New York, New York 10032
Stony Brook, New York 11794
Columbus, Ohio 043210
Oklahoma City, Oklahoma 73104
Danville, Pennsylvania 17822
Philadelphia, Pennsylvania 19104
Nashville, Tennessee 37205
Seattle, Washington 98122
Milwaukee, Wisconsin 23215
More Details
- NCT ID
- NCT02146066
- Status
- Available
- Sponsor
- Northwest Biotherapeutics
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.