Expanded Access Program for GBM Patients with DCVax®-L Vaccine Who Couldn't Join the Original Study

Sponsor: Northwest Biotherapeutics

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02146066

Provider View

This program offers access to the DCVax®-L vaccine for patients with glioblastoma (GBM) who couldn't join the original study due to specific reasons. Patients will receive the vaccine along with standard care as decided by their doctor.

Patient Parameters

Program Overview

This program is for patients with glioblastoma (GBM) who had a DCVax®-L vaccine made for them but couldn't join the original study. These patients will receive the vaccine according to a set schedule, along with their usual treatment. The program aims to include about 99 patients.

Description

Patients who couldn't join the original study because their disease progressed after chemo-radiation or because not enough vaccine doses were made can join this program. The vaccine will be given on specific days: 0, 10, 20, and then at months 2, 4, 8, 12, 18, 24, and 30. There are no strict rules about other treatments, but guidelines are suggested. Information about the vaccine and any side effects will be collected. MRIs will be reviewed to track disease progression and survival.

Eligibility Criteria

Inclusion Criteria

  • Couldn't join the original study because:
    • Their disease progressed or seemed to progress at the start of the original study, OR
    • Not enough vaccine doses were made (less than 5 doses).
  • Must have a performance status score of 70 or higher.
  • May have used steroids as part of their treatment. Steroid use should be stopped or reduced to no more than 4 mg of dexamethasone daily at least 7 days before the first vaccine dose.
  • Must have a DCVax-L vaccine made and ready.

Exclusion Criteria

  • Have an active, uncontrolled infection or need antibiotics or antifungal treatment. These treatments should be finished about 7 days before the first vaccine dose.
  • Have a fever of 101.5°F or higher. If the fever might be temporary, retesting is allowed.
  • Have unstable or severe medical conditions.
  • Women who are pregnant, breastfeeding, or not using effective birth control methods.

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