ISRCTN45828668
Completed
Not Applicable
A phase I - II, prospective, double blind, randomised study of the safety and efficacy of sulfasalazine for the treatment of progressing malignant gliomas
niversity of Liege, Department of Neurosurgery (Belgium)0 sites20 target enrollmentDecember 15, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Progressive malignant glioma (astrocytic)
- Sponsor
- niversity of Liege, Department of Neurosurgery (Belgium)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients aged greater than 18 years
- •2\. With recurrent or progressive World Health Organization (WHO) grade 3 or 4 astrocytic gliomas after surgery
- •3\. Standard radiation therapy
- •4\. A first line of conventional chemotherapy (e.g. temozolomide, CCNU or BCNU)
- •Recurrence or progression prior to inclusion are based on MacDonald?s criteria. Patients are thoroughly informed about the nature of their disease, suspected prognosis, study background and objectives and potential alternative treatments. This information is provided both orally and in written form, prior to obtaining written informed consent from the patient.
Exclusion Criteria
- •1\. Present with anaplastic oligodendroglioma (WHO grade 3\)
- •2\. Allergy to sulfa drugs
- •3\. Porphyria
- •4\. G\-6\-PD deficiency
- •5\. Psychiatric disorder deemed incompatible with compliance to the study
- •6\. Creatinine greater than 15 mg/l
- •7\. Aspartate aminotransferase (TGO) greater than 200 UI/l
- •8\. Amylase greater than 150 UI/l
- •9\. Pregnant or lactating women
- •10\. Patients may not have received any other experimental medication within 30 days (and at least five drug half\-lives) prior to inclusion
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Diabetic Foot UlcerHealth Condition 1: null- Diabetic Foot UlcerCTRI/2011/09/001984FirstString Research Inc92
Completed
Phase 2
To study the Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Venous Leg UlcerHealth Condition 1: null- Venous Leg UlcerCTRI/2011/09/001985FirstString Research Inc92
Completed
Phase 2
To Study Safety and Efficacy of GRANEXIN GEL plus Standard of Care as compared to standard of Care alone in reducing scar formation in wounds following laparoscopic surgeryHealth Condition 1: null- Scar Formation in Surgical Incisional Wounds following Laparoscopic SurgeryCTRI/2011/09/002004FirstString Research Inc92
Recruiting
Phase 1
A Phase 1 study to evaluate safety and tolerability of Anti-PCSK9 Product (ZRC-3306) administered subcutaneously in healthy adult human subjectsCTRI/2024/01/062126Zydus Lifesciences Ltd Formerly Cadila Healthcare Limited
Completed
Phase 1
A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human SubjectsCTRI/2021/08/035449Cadila Healthcare Ltd24