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

Phase 1

• Conditions: Adults with newly diagnosed glioblastoma multiforme

• Registration Number: EUCTR2006-002881-20-BE
• Lead Sponsor: niversity Hospital Gasthuisberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-02
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

* Age: > 18 years and < 70 years; * First diagnosis of high grade glioma (glioblastoma multiforme WHO grade IV), histologically proven; * Diagnosis confirmed by the reference pathology; * Total or subtotal resection of tumor mass, confirmed by assessment by the neurosurgeon ( 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

* 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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