Glioblastoma Multiforme Clinical Trial
Official title:
Immunophenotyping From Blood From Patients With Glioblastoma and Anaplastic Astrocytoma Before and During Chemoradiation as Well as During Adjuvant Chemotherapy
Verified date | February 2023 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this explorative study immunological changes during tumor therapy will be analyzed in patients with malignant glioma. Immunophenotyping before and during therapy is used as analysis method. Thereby immune cells are quantitatively and qualitatively detected from patient's blood at continuous time points. Additionally relevant mediators like cytokines, danger signals and chemokines are analyzed by other methods. Obtained results may give information about the effects of therapy on immunological processes and immune cells and may help to find immunological based predictive or prognostic tumor markers and to define time points for including additional immune therapy in the future.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients with glioblastoma or anaplastic astrocytoma - legal age - planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.) Exclusion Criteria: - Fertile patients who refuse effective contraception during study treatment - persistent drug and/or alcohol abuse - patients not able or willing to behave according to study protocol - patients in care - patients that are not able to speak German |
Country | Name | City | State |
---|---|---|---|
Germany | Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg | Erlangen | BAY |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | immunological state of patients comprising number, type and activation state of immune cells, cytokines and danger signals from peripheral blood | Time points for blood sample collections:
Before start of chemoradiation (RCT). In 3th week of RCT. At last day of RCT. At the beginning of chemotherapy (CT) (about 4 weeks after RCT). During CT each three to four weeks. At follow-up visits each one to three months. During recurrence therapy. |
patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | |
Secondary | Acquisition of toxicities according to Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | ||
Secondary | documentation of medication | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | ||
Secondary | Acquisition of changes in imaging | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | ||
Secondary | Acquisition of life quality according to quality of life questionnaire (QLQ) (EORTC QLQ -BN20) | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | ||
Secondary | correlation of immunological parameters with clinical data | Correlation with results of immunophenotyping, possibly definition of medically relevant markers | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | |
Secondary | overall survival | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months | ||
Secondary | progression free survival | patients will be followed for the duration of therapy and follow-up until recurrence, an expected average of 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05023551 -
Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
|
Early Phase 1 | |
Recruiting |
NCT06059690 -
Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells
|
Phase 1/Phase 2 | |
Recruiting |
NCT04116411 -
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
|
Phase 2 | |
Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00038493 -
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Recruiting |
NCT01923922 -
CT Perfusion in the Prognostication of Cerebral High Grade Glioma
|
N/A | |
Completed |
NCT01956734 -
Virus DNX2401 and Temozolomide in Recurrent Glioblastoma
|
Phase 1 | |
Completed |
NCT01301430 -
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
|
Phase 1/Phase 2 | |
Suspended |
NCT01386710 -
Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
|
Phase 1/Phase 2 | |
Completed |
NCT01402063 -
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
|
Phase 2 | |
Active, not recruiting |
NCT00995007 -
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
|
Phase 2 | |
Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Terminated |
NCT00990496 -
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
|
Phase 1 | |
Completed |
NCT00402116 -
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00504660 -
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
|
Phase 2 | |
Recruiting |
NCT05366179 -
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
|
Phase 1 |