Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (DCVax-L EAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02146066|
Expanded Access Status : Available
First Posted : May 23, 2014
Last Update Posted : February 26, 2016
|Condition or disease||Intervention/treatment|
|GBM Glioblastoma Multiforme||Biological: DCVax-L|
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.
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|
- Biological: DCVax-L
Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen
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
|Contact: Marnix Bosch, MBA PhD||240 497 firstname.lastname@example.org|
|Contact: Meghan Swardstrom||425 492 email@example.com|