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Early termination of ISRCTN45828668, a phase 1/2 prospective, randomized study of Sulfasalazine for the treatment of progressing malignant gliomas in adults
BMC Cancer, 10/22/09

Robe PA et al. – Although the proper influence of sulfasalazine treatment on patient outcome was difficult to ascertain in these debilitated patients with a large tumor burden (median KPS=50), ISRCTN45828668 was terminated after its interim analysis. This study urges to exert cautiousness in future trials of Sulfasalazine for the treatment of malignant gliomas

• 10 patients with advanced recurrent anaplastic astrocytoma (n=2) or glioblastoma (n=8) aged 32-62 years recruited prior to planned interim analysis of study
• Subjects randomly assigned to daily doses of 1.5, 3, 4.5, or 6 grams of oral sulfasalazine, and treated until clinical or radiological evidence of disease progression or development of serious or unbearable side effects
• Primary endpoints were evaluation of toxicities according to CTCAE v.3.0, and observation of radiological tumor responses based on MacDonald criteria

• No clinical response observed
• One tumor remained stable for 2 months with sulfasalazine treatment, at the lowest daily dose of drug
• Median progression-free survival was 32 days
• Side effects common, as all patients developed grade 1-3 adverse events (mean: 7.2/patient), four patients developed grade 4 toxicity
• 2 patients died while on treatment or shortly after discontinuation

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