HGG-2006: a phase I/II clinical trial for the treatment of newly diagnosed high grade glioma with tumor vaccination as "add-on therapy" to standard primary treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002881-20-BE

Enrollment

Registered

2006-06-02

Start date

2006-08-17

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults with newly diagnosed glioblastoma multiforme

Interventions

Product Name: DC Product Code: DC Pharmaceutical Form: Injection* Other descriptive name: Autologous Dendritic cells Concentration unit: µl microlitre(s) Concentration type: range Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Age: > 18 years and 3 months; * Informed consent by patient. The final and definitive inclusion in the trial can only be done at the trial center in Leuven after considering all the necessary information on the clinical, pathological and radiological data. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Pregnancy; * Patients with postoperative Karnofsky index < 70; * Simultaneous treatment according to other clinical trials; * Virus serology positive for Hepatitis, syphilis or HIV; * Blood counts: Leukocytes < 3000/µl, lymphocytes < 500/µl, neutrophils < 1000/µl, hemoglobin < 9 g/100 ml, thrombocytes < 100000/µl at day 10, about 2 days prior to leukapheresis; * Documented immune deficiency; * Documented autoimmune disease; * Mandatory treatment with corticosteroids or salicylates in inflammatory dose; * Other active malignancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The first aim of this study is to assess the feasibility/toxicity to integrate tumor vaccination within the global treatment plan for a patient with newly diagnosed HGG. The major primary aim will be the event-free survival at 6 months (PFS) after diagnosis. ;Secondary Objective: The secondary end-point will be the OS of the patients. A further secondary question is to assess the efficacy to generate an immune response in combination with non-immunosuppressive chemotherapy. ;Primary end point(s): PFS at 6m	—

Measure

Time frame

Main Objective: The first aim of this study is to assess the feasibility/toxicity to integrate tumor vaccination within the global treatment plan for a patient with newly diagnosed HGG. The major primary aim will be the event-free survival at 6 months (PFS) after diagnosis. ;Secondary Objective: The secondary end-point will be the OS of the patients. A further secondary question is to assess the efficacy to generate an immune response in combination with non-immunosuppressive chemotherapy. ;Primary end point(s): PFS at 6m

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 26, 2026