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Convection-enhanced intra-tumoral delivery of taxol for recurrent glioblastoma. Results of a phase I clinical study. Conclusion: Significant antitumor responses were seen.

Posted on: 05/24/2002

Convection-enhanced intra-tumoral delivery of taxol for recurrent glioblastoma. Results of a phase I clinical study.

Raphael M Pfeffer, Zvi Lidar, Jacob Baram, Tali Jonas, Meir Faibel, Dvora Nass, Zvi Ram, Yael Mardor, Chaim Sheba Medical Center, Tel-Hashomer, Israel.

Recurrent glioblastoma after radiotherapy carries a dismal prognosis. Few patients respond to systemic chemotherapy. Intra-tumoral convection-enhanced delivery (CED) is a novel approach that allows intratumoral drug distribution via a catheter placed within the tumor. Paclitaxel is active against glioblastoma in vitro but does not cross the blood brain barrier. We present the results of a phase I study to investigate the safety and efficacy of CED of paclitaxel for histologically confirmed recurrent glioblastoma. Nine patients were enrolled in the study. Four received 2 treatment cycles. The first 3 patients received a dose of 7 mg paclitaxel/day at a rate of 5├ČL/hr for up to 5 days (total dose 35 mg). Two patients developed increased peri-tumoral edema, somnolence, and chemical meningitis, that subsided after 4-5 days. Therefore in the following 6 patients the dose was reduced to 3.5 mg paclitaxel/day for up to 5 days (total dose 17.5 mg). The diffusion pattern in tumor and normal brain and response to therapy were monitored by diffusion weighted MRI (Mardor, Cancer Research 61:4971, 2001). Two patients whose tumor reached the ventricle developed chemical meningitis after leakage of paclitaxel into the ventricle. The other patients showed no acute toxicity. Two patients had delayed skin wound healing. Eight of 9 evaluable patients showed tumor shrinkage and rapid resolution of enhancement and peritumoral edema. Four showed CR and 4 PR. One patient with a cystic tumor did not respond. Tissue specimens were obtained from 3 patients. In 2 patients no viable tumor was seen and in one, minimal residual tumor was detected at the remote edges of the resected tumor. DWMRI showed that the convection wave was distributed preferentially within tumor tissue rather than normal brain. Intra-tumoral convection enhanced paclitaxel can be delivered safely in patients with recurrent glioblastoma. Significant antitumor responses were seen.
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