8 completed, 2 withdrawn, 1 terminated. 10 Phase 1, 5 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 7, Withdrawn 2, Terminated 1 |
| Phase 2 | 5 | Completed 3, Withdrawn 2 |
| Phase 3 | 1 | Completed 1 |
Follow IL13-PE38: new trials by email Literature Review of IL13-PE38 trials Research Report on IL13-PE38
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Open Label Dose Escalation Safety Study of Convection-Enhanced Delivery of IL13-PE38QQR in Patients With Progressive Pediatric Diffuse Infiltrating Brainstem Glioma and Supratentorial High-grade Glioma IL13-PE38QQR - Brain Neoplasm, Glioma | Phase 1 | Terminated | National Institute of Neurological Disorders and Stroke (NINDS) | 7 | 2009-04-07 | 2018-07-05 |
| Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas cintredekin besudotox, conventional surgery - Brain and Central Nervous System Tumors | Phase 1 / Phase 2 | Withdrawn | Pediatric Brain Tumor Consortium | 2005-10-01 | 2010-09-24 | |
| IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma IL13-PE38QQR, Surgery for placement, Radiation therapy - Glioblastoma Multiforme, Anaplastic Astrocytoma | Phase 1 | Completed | INSYS Therapeutics Inc | 24 | 2004-07-01 | 2011-07-04 |
| The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme IL13-PE38QQR, surgery and catheter placement (2 procedures), prolifespan 20 with carmustine implant (GLIADEL® Wafer) - Glioblastoma Multiforme | Phase 3 | Completed | INSYS Therapeutics Inc | 300 | 2004-02-01 | 2011-06-06 |
| Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma IL13-PE38QQR, targeted fusion protein therapy, surgery - Malignant Glioma, Glioblastoma Multiforme | Phase 1 | Completed | INSYS Therapeutics Inc | 18 | 2003-07-01 | 2011-06-06 |
| Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma IL13-PE38QQR, targeted fusion protein therapy, surgery - Malignant Glioma, Glioblastoma Multiforme | Phase 1 / Phase 2 | Completed | INSYS Therapeutics Inc | 80 | 2002-07-01 | 2011-06-06 |
| Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma cintredekin besudotox, adjuvant therapy, conventional surgery - Brain and Central Nervous System Tumors | Phase 1 | Completed | Memorial Sloan Kettering Cancer Center | 2001-11-01 | 2013-06-26 | |
| Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients IL13-PE38QQR, targeted fusion protein therapy, surgery - Malignant Glioma, Glioblastoma Multiforme | Phase 1 | Completed | INSYS Therapeutics Inc | 40 | 2001-06-01 | 2011-06-06 |
| Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma IL13-PE38QQR, targeted fusion protein therapy, surgery - Malignant Glioma, Glioblastoma Multiforme | Phase 1 / Phase 2 | Completed | INSYS Therapeutics Inc | 60 | 2000-11-01 | 2014-11-14 |
| Immunotoxin Therapy in Treating Patients With Malignant Glioma cintredekin besudotox, isolated perfusion, conventional surgery - Brain and Central Nervous System Tumors | Phase 1 / Phase 2 | Completed | New Approaches to Brain Tumor Therapy Consortium | 2000-10-01 | 2013-06-24 | |
| Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma IL13-PE38QQR - Recurrent Malignant Glioma | Phase 1 / Phase 2 | Withdrawn | INSYS Therapeutics Inc | 2014-11-13 |
Glioma (10) · Glioblastoma (8) · Astrocytoma (7) · Brain Neoplasms (6) · Central Nervous System Neoplasms (4) · Recurrence (3) · Gliosarcoma (2) · Neoplasms (1) · Oligodendroglioma (1)
INSYS Therapeutics Inc (7) · Memorial Sloan Kettering Cancer Center (1) · National Institute of Neurological Disorders and Stroke (NINDS) (1) · New Approaches to Brain Tumor Therapy Consortium (1) · Pediatric Brain Tumor Consortium (1)
United States (10) · Germany (2) · Israel (2) · Canada (1) · Netherlands (1) · United Kingdom (1)
Jon Weingart, MD (2) · Anuradha Banerjee, MD (1) · Anuradha Banerjee, MD, MPH (1) · John D Heiss, M.D. (1) · Lauren E. Abrey, MD (1)