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 Sex
- 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 4119403, Arkansas 4099753 72205
Los Angeles 5368361, California 5332921 90095
Newport Beach 5376890, California 5332921 92663
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
Aurora 5412347, Colorado 5417618 80045
Englewood 5421250, Colorado 5417618 80113
Gainesville 4156404, Florida 4155751 32611
Hollywood 4158928, Florida 4155751 33021
Warrenville 4915525, Illinois 4896861 60555
Boston 4930956, Massachusetts 6254926 02215
Grand Rapids 4994358, Michigan 5001836 49503
Minneapolis 5037649, Minnesota 5037779 55407
Kansas City 4393217, Missouri 4398678 64111
St Louis 4407066, Missouri 4398678 63110
Hackensack 5098706, New Jersey 5101760 07601
Trenton 5105496, New Jersey 5101760 08638
Manhasset 5125766, New York 5128638 11030
New York 5128581, New York 5128638 10032
Stony Brook 5139865, New York 5128638 11794
Columbus 4509177, Ohio 5165418 043210
Oklahoma City 4544349, Oklahoma 4544379 73104
Danville 5186327, Pennsylvania 6254927 17822
Philadelphia 4560349, Pennsylvania 6254927 19104
Nashville 4644585, Tennessee 4662168 37205
Seattle 5809844, Washington 5815135 98122
Milwaukee 5263045, Wisconsin 5279468 23215
More Details
- 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.