A phase I - II, prospective, double blind, randomised study of the safety and efficacy of sulfasalazine for the treatment of progressing malignant gliomas

Completed

Conditions: Cancer
Progressive malignant glioma (astrocytic)
Malignant glioma

Registration Number: ISRCTN45828668

Lead Sponsor: niversity of Liege, Department of Neurosurgery (Belgium)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

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
11. Patients cannot concomitantly take mercaptopurine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The maximal daily oral dose of sulfaslazine that is tolerated by patients with recurrent or progressive malignant gliomas. Measurements will include the nature, frequency, possible causality and severity of adverse events that occur during treatment<br>2. The assessment of any clinical and/or radiological response of individual tumours to sulfasalazine

Secondary Outcome Measures