Study of new compounds in the treatment of brain tumors: drug levels and signs of effect inside the tumor tissue (INSIDE)

Phase 1

• Conditions: Glioblastoma; MedDRA version: 19.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004471-46-SE
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-11
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. A suspected glioblastoma (based on MRI) or recurrent glioblastoma undergoing surgical resection.
2. Elective surgical indication.
3. Age 18 years or older.
4. Karnofsky performance status of 60 – 100.
5. Not receiving another experimental treatment for glioblastoma at the moment of inclusion.
6. Able to take oral medications.
7. No known allergy to substance.
8. Absolute neutrophil count = 1,500/mcL and platelets = 100,000/mcL.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Other likely diagnosis than glioblastoma based on MRI.
2. Pregnant and/or breastfeeding.
3. Women of childbearing potential who do not have a negative pregnancy test (not older than 14 days) before inclusion.
4. History of active liver disease, including chronic active hepatitis, viral hepatitis (hepatitis B, C and CMV), cholestatic jaundice of any etiology or toxic hepatitis or inadequate hepatic function, defined as baseline ASAT and ALAT > 1.5 X upper institutional limit and/or bilirubin > 1.5 X upper institutional limit.
5. Suspected significant raised intracranial pressure or other indication for emergent surgery.
6. Unfit for participation for any other reason judged by the including physician.
7. Unfit for participation due to any substance specific contraindications

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate tissue levels and target effect of :<br>a) disulfiram with copper-supplement and<br>b) metformin;Secondary Objective: Not applicable;Primary end point(s): To assess concentrations and target effects of the study drugs. ;Timepoint(s) of evaluation of this end point: At visit 3, during surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Events of toxicity/safety occurring from inclusion to 14-21 days postoperatively will be reported according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 ;Timepoint(s) of evaluation of this end point: As specified in E.5.2