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

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.

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.