PURPOSE: To determine the response rate, time to disease progression, survival, 
and toxicity of intravenous carboplatin and chronic oral high-dose tamoxifen in 
patients with recurrent malignant gliomas.
PATIENTS AND METHODS: Patients with histological confirmation of recurrent 
malignant gliomas were eligible for this multicenter phase II trial. Treatment 
consisted of 400 mg/m2 carboplatin intravenously every 4 weeks and oral high 
dose chronic tamoxifen (80 mg bid in women and 100 mg bid in men).
RESULTS: Twenty seven patients met the eligibility criteria and were evaluable 
for response. The histological subtypes were: 16 (59%) glioblastoma multiforme 
(GBM), malignant astrocytoma (5 patients), malignant mixed glioma (5 patients), 
and glioblastoma/gliosarcoma (1 patient). Twenty-two patients (82%) had an ECOG 
performance status of 0 or 1. No complete responses were observed, 4 patients 
(15%) achieved a partial response, and 14 patients (52%) had stable disease. 
Median time to progression was 3.65 months (95%CI 2.56, 4.83). Median overall 
survival was 14.09 months (95%CI 7.06, 19.91). One patient with a recurrent GBM 
had a sustained partial response and is progression free 81 months since 
starting treatment. Another patient with mixed malignant oligoastrocytoma also 
had a prolonged partial response (lasting 63 months) and is alive 84 months 
after treatment for recurrence. The most frequently reported grade 3 or 4 
toxicities were fatigue (19%), nausea (11%) and anorexia (11%).
CONCLUSIONS: Carboplatin and high dose tamoxifen has similar response rates to 
other regimens for recurrent malignant gliomas and are probably equivalent to 
those found using tamoxifen as monotherapy. Long-lasting periods of disease free 
survival in some patients (particularly those with malignant mixed oligo 
astrocytomas) were found.