Human phase 1/2 clinical study of the safety and efficacy of sulfasalazine as a therapy for recurrent or progressing high grade gliomas. - Sulfasalazine in malignant gliomas

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004392-11-BE

Enrollment

Registered

2005-07-15

Start date

2005-03-03

Completion date

Unknown

Last updated

2024-04-02

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

Conditions

Recurrent or progressive high grade glioma, including gliobastoma, anaplastic astrocytoma and oligo-astrocytoma.

Interventions

Trade Name: Salazopyrine Product Name: Sulfasalazine Product Code: not applicable Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Ocu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. adult patient ( age > 18 years); 2. Histologically-proven diagnostic of glioblastoma, anaplastic astrocytoma or anaplastic oligo-astrocytoma; 3. the patient has at least undergone one course of surgery and radiation therapy ( standard treatment) and shows signs of tumor pregression or recurrence; 4. The patient has signed an informed consent form. 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: 1. Histological diagnostic of anaplastic oligodendroglioma 2. Allergy to sulfa drugs 3. Psychiatric condition deemed incompatible with compliance to the study protocol 4. The patient has received another experimental treatment whithin the previous 30 days 5. Severe alteration of kidney, liver or pancreas function 6. Porphyria of any kind 7. G-6-PD deficiency 8. Pregant or lactating woman 9. Concomittant treatment with mercaptopurine

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To determine the tolerability and potential adverse effects of Sulfasalazine as a treatemnt for recurrent high grade gliomas whithin the range of 1.5 to 6 grams/day of this medication; 2. To assess the radiological and clinical response of these tumors to sulfasalazine;Secondary Objective: To determine the overall survival and progression-free survival of patients recieving sulfasalzine for the treatemnt of recurrent or progressive high grade glioma.;Primary end point(s): 1. Evidence of progression of the tumor on two consecutive follow-up MRI scans; 2. Complete tumor remission as defined as the disappearance of enhancing lesion on two consecutive follow-up MRI scans 3. Intolerance to the treatment and decision of the patient to withdraw from the study 4. Serious adverse effect due to the treatment 5. Death of the patient	—

Measure

Time frame

Main Objective: 1. To determine the tolerability and potential adverse effects of Sulfasalazine as a treatemnt for recurrent high grade gliomas whithin the range of 1.5 to 6 grams/day of this medication; 2. To assess the radiological and clinical response of these tumors to sulfasalazine;Secondary Objective: To determine the overall survival and progression-free survival of patients recieving sulfasalzine for the treatemnt of recurrent or progressive high grade glioma.;Primary end point(s): 1. Evidence of progression of the tumor on two consecutive follow-up MRI scans; 2. Complete tumor remission as defined as the disappearance of enhancing lesion on two consecutive follow-up MRI scans 3. Intolerance to the treatment and decision of the patient to withdraw from the study 4. Serious adverse effect due to the treatment 5. Death of the patient

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026