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

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ClinicalTrials.gov Identifier: NCT02146066
Expanded Access Status : Available
First Posted : May 23, 2014
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
GBM Glioblastoma Multiforme Biological: DCVax-L

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 Type : Expanded Access
Official Title: An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients With Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221



Intervention Details:
  • Biological: DCVax-L
    Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146066


Contacts
Contact: Marnix Bosch, MBA PhD 240 497 9022 marnix@nwbio.com
Contact: Meghan Swardstrom 425 492 6036 mswardstrom@nwbio.com

  Show 27 Study Locations
Sponsors and Collaborators
Northwest Biotherapeutics

Responsible Party: Northwest Biotherapeutics
ClinicalTrials.gov Identifier: NCT02146066     History of Changes
Other Study ID Numbers: 0202EA
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by Northwest Biotherapeutics:
GBM
Brain tumor
glioblastoma
Brain tumor WHO grade IV

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue