Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy (DEN-STEM)
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|ClinicalTrials.gov Identifier: NCT03548571|
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: Dendritic cell immunization Drug: Adjuvant temozolomide||Phase 2 Phase 3|
Autologous leukapheresis for enrichment of PBMCs is performed after enrollment of the patient into the trial. Ex vivo generated DCs will be frozen and stored in the vapour phase of liquid nitrogen.
At first surgery, tumor biopsies will be cultured under sphere-forming conditions under ex vivo conditions for enrichment of glioblastoma stem cells. mRNA will purified and amplified from these autologous tumor stem cells.
At specified intervals patients randomized to the vaccine group will receive intradermal injections of DCs transfected with mRNA from autologous tumor stem cells, survivin and hTERT. Injections will be given as three separate injections at three separate sites.
Vaccination will be continued for as long as there are vaccines available.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open label, randomized|
|Masking:||None (Open Label)|
|Official Title:||Open Label Randomized Phase II/III Trial of Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy (DEN-STEM)|
|Actual Study Start Date :||April 26, 2018|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2023|
Experimental: DC immunization
Leukapheresis before start of radiotherapy. Immunization with DCs starting first week after finalizing radiotherapy (2Gy x 30) and concomitant temozolomide.
Biological: Dendritic cell immunization
Active Comparator: Standard therapy
Radiotherapy (2 Gy x30) with concomitant and adjuvant temozolomide.
Drug: Adjuvant temozolomide
After a 4-week break, patients were then to receive up to six cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days at 150 mg per square meter for the first cycle and thereafter increase to 200 mg per square meter beginning with the second cycle.
Other Name: Standard therapy
- Progression free survival [ Time Frame: 2 years ]Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria.
- Overall survival [ Time Frame: 2 years from inclusion ]Survival from the time of diagnosis.
- Patient reported quality of life, overall [ Time Frame: 2 years from inclusion ]Evaluated by EORTC Quality of Life Questionaire (QLQ-C30), a questionnaire developed to assess the quality of life of cancer patients. Scale 30 to 120 points, where higher is worse.
- Patient reported quality of life, brain specific [ Time Frame: 2 years from inclusion ]Evaluated by EORTC Quality of Life Questionaire, Brain module (QLQ-BN20). The brain cancer module is meant for use among brain cancer patients varying in disease stage and treatment modality. Scale 20 to 80 points, where higher is worse. It should always be complemented by the QLQ-C30.
- Immunological response, skin [ Time Frame: 2 years from inclusion ]Evaluated by delayed type hypersensitivity reaction in skin.
- Immunological response, cellular [ Time Frame: 2 years from inclusion ]Evaluated by lymphocyte clonal analysis.
- Adverse events [ Time Frame: 2 years from inclusion ]Classified according to Common Terminology Criteria for Adverse Events (CTCAE).
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): NCT03548571
|Contact: Einar O Vik-Mo, MD, PhD||+47 email@example.com|
|Contact: Soveig Bringslifirstname.lastname@example.org|
|Principal Investigator:||Iver A Langmoen, MD, PhD||Oslo University Hospital|