PMID- 15930352 OWN - NLM STAT- MEDLINE DCOM- 20050829 LR - 20220330 IS - 1078-0432 (Print) IS - 1078-0432 (Linking) VI - 11 IP - 11 DP - 2005 Jun 1 TI - Clinical evaluation of dendritic cell vaccination for patients with recurrent glioma: results of a clinical phase I/II trial. PG - 4160-7 AB - PURPOSE: To investigate the safety and the immunologic and clinical responses of dendritic cell therapy for patients with recurrent malignant glioma. EXPERIMENTAL DESIGN: Twenty-four patients with recurrent malignant glioma (6 grade 3 and 18 grade 4 patients) were evaluated in a phase I/II clinical study of dendritic cell therapy. All patients were resistant to the standard maximum therapy. The patient's peripheral blood dendritic cells were generated with granulocyte macrophage colony-stimulating factor, plus interleukin 4 with or without OK-432, and pulsed with an autologous tumor lysate. Dendritic cells were injected intradermally, or both intratumorally and intradermally every 3 weeks. RESULTS: The protocols were well tolerated with only local redness and swelling at the injection site in several cases. Clinical responses were as follows: 1 patient with partial response, 3 patients with minor response, 10 patients with stable disease, and 10 patients with progressive disease. The patients whose dendritic cells were matured with OK-432 had longer survival times than the dendritic cells from patients without OK-432 maturation. The patients with both intratumoral and intradermal administrations had a longer survival time than the patients with intradermal administration only. Increased ELISPOT and delayed-type hypersensitivity responses after vaccination could provide good laboratory markers to predict the clinical outcome of patients receiving dendritic cell vaccination. The overall survival of patients with grade 4 glioma was 480 days, which was significantly better than that in the control group. CONCLUSIONS: This study showed the safety and clinical response of autologous tumor lysate-pulsed dendritic cell therapy for patients with malignant glioma. Dendritic cell therapy is recommended for further clinical studies in malignant glioma patients. FAU - Yamanaka, Ryuya AU - Yamanaka R AD - Department of Neurosurgery, Brain Research Institute, Niigata University School of Medicine, Niigata University, Niigata, Japan. ryaman@bri-niigata-u.ac.jp FAU - Homma, Junpei AU - Homma J FAU - Yajima, Naoki AU - Yajima N FAU - Tsuchiya, Naoto AU - Tsuchiya N FAU - Sano, Masakazu AU - Sano M FAU - Kobayashi, Tsutomu AU - Kobayashi T FAU - Yoshida, Seiichi AU - Yoshida S FAU - Abe, Takashi AU - Abe T FAU - Narita, Miwako AU - Narita M FAU - Takahashi, Masuhiro AU - Takahashi M FAU - Tanaka, Ryuichi AU - Tanaka R LA - eng PT - Clinical Trial PT - Clinical Trial, Phase I PT - Clinical Trial, Phase II PT - Journal Article PL - United States TA - Clin Cancer Res JT - Clinical cancer research : an official journal of the American Association for Cancer Research JID - 9502500 RN - 0 (Cancer Vaccines) SB - IM MH - Adult MH - Aged MH - Cancer Vaccines/administration & dosage/immunology MH - Dendritic Cells/*immunology MH - Female MH - Glioma/mortality/pathology/*therapy MH - Humans MH - Immunotherapy, Adoptive/methods MH - Injections, Intradermal MH - Injections, Intralesional MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local MH - Survival Rate MH - Treatment Outcome EDAT- 2005/06/03 09:00 MHDA- 2005/08/30 09:00 CRDT- 2005/06/03 09:00 PHST- 2005/06/03 09:00 [pubmed] PHST- 2005/08/30 09:00 [medline] PHST- 2005/06/03 09:00 [entrez] AID - 11/11/4160 [pii] AID - 10.1158/1078-0432.CCR-05-0120 [doi] PST - ppublish SO - Clin Cancer Res. 2005 Jun 1;11(11):4160-7. doi: 10.1158/1078-0432.CCR-05-0120.