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

• Conditions: GBM; Glioblastoma Multiforme

• Registration Number: NCT02146066
• Lead Sponsor: Northwest Biotherapeutics

Brief 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.

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.

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (27)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hospital; 🇺🇸 Newport Beach, California, United States

St. Joseph Hospital of Orange; 🇺🇸 Orange, California, United States

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Colorado Neurological Institute; 🇺🇸 Englewood, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Memorial Healthcare System Memorial Cancer Institute; 🇺🇸 Hollywood, Florida, United States

Cadence Cancer Center at Warrenville; 🇺🇸 Warrenville, Illinois, United States

Scroll for more (17 remaining)