NABTT Protocols

Class A: Newly Diagnosed Glioblastoma, with measurable disease
Class B: Newly Diagnosed Glioblastoma, with or without measurable disease
Class C: Recurrent High Grade Astrocytoma, with measurable disease
Class D: Locally Recurrent High Grade Astrocytoma
Class E: Histology other than High Grade Astrocytoma

Class F: Non "Therapeutic" Protocols

CLASS A

• Active Protocols

  • None currently

• Protocols In Development (Expanded Information Not Available)

  • None currently

• Completed Protocols (Information Regarding these protocols may be found in the Reference List)

  • Phase I/II Clinical and Pharmacologic Dose Escalation Study of Pre-Irradiation Taxol Administered as a 96 Hour Infusion in Adults with Newly Diagnosed Glioblastoma Multiforme

  • Phase I/II Clinical and Pharmacologic Study of Pre-Irradiation 9-Amino-20(S)-Camptothecin (9-AC) Administered as a 72 Hour Infusion in Adults with Newly Diagnosed Glioblastoma

  • Phase I/II Study of CI-980 in Adults with Newly Diagnosed Malignant Gliomas

  • Phase II Study of R115777 for the Treatment of Adults with Newly Diagnosed Glioblastoma Multiforme

  • Phase I/II Study of Pyrazoloacridine (PZA) in Adults with Newly Diagnosed Glioblastoma Multiforme

  • Phase II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults with Newly Diagnosed Malignant Glioma

CLASS B

• Active Protocols

  • Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Gliomas

  • A Safety Run-In/Randomized Phase II Trial of EMD 121974 in Conjunction with Concomitant Temozolomide and Adjuvant Temozolomide withRadiation Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme

  • A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients with Newly Diagnosed Glioblastoma Multiforme

  • A Phase I, Open Label Study of AT-101 Plus Radiotherapy and Temozolomide for Patients with Newly-Diagnosed Glioblastoma Multiforme

• Protocols In Development (Expanded Information Not Available)

  • A Phase I/II Trial of Hydroxychloroquine in Conjunction with Radiation Therapy and Concurrent and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme

  • A Phase I Trial of Daily Adjuvant Temozolomide and ABT-888 in Patients with Newly Diagnosed Glioblastoma Multiforme

• Completed Protocols (Information Regarding these protocols may be found in the Reference List)

  • A Phase Ib Study to Evaluation the Safety and Tolerance of Repetitive Daily Intravenous Doses of RSR13 Administered to Patients Receiving Cranial Radiation Therapy for Glioblastome Multiforme
  • Phase II Study of RSR-13 + Radiation in Adults with Newly Diagnosed Glioblastoma Multiforme
  • Phase II Study of Penicillamine and Reduction of Copper for Angiosuppresive Therapy of Adults with Newly Diagnosed Glioblastoma
  • Phase II Clinical and Pharmacologic Study of CAI Post-Irradiation in Adults with Resected Newly Diagnosed Glioblastoma Multiforme
  • Phase II Study of Suramin and Radiation Therapy in the Treatment of Newly Diagnosed Glioma
  • A Phase I Trial to Evaluate Repetitive Intravenous Doses of Gadolinium-Texaphyrin as a Radiosensitizer in Patients with Glioblastoma Multiforme (this trial requires measurable disease)
  • A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients with Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
  • A Phase II Trial of Talampanel in Conjunction with Radiation Therapy with Concurrent and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme

CLASS C

• Active Protocols

  • Phase I Evaluation of the Safety of PS341 in the Treatment of Recurrent Gliomas

  • A Phase I, Open Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients with MTAP-Deficient High Grade Recurrent Malignant Gliomas

  • A Phase I Trial of BAY 43-9006 for Patients with Recurrent or Progressive Malignant Gliomas

  • Open-Label Phase I/Phase II Study of Intravenous Infusion of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects with Recurrent High Grade Glioma

  • A Phase 2 Trial of OSI-774 and BAY 43-9006 for Patients with Progressive or Recurrent Glioblastoma Multiforme

  • A Feasibility Assessment and a Phase I/II Trial of MLN518 for Treatment of Patients with Recurrent Glioblastoma

• Protocols In Development (Expanded Information Not Available)

  • A Phase I Imaging and Safety Study of Intravenous ¹³¹I-TM-601 Labeled Chlorotoxin in Patients with Recurrent Malignant Glioma

  • A Phase 2 Study of R-(-)-gossypol (Ascenta's AT-101) in Recurrent Glioblastoma Multiforme

• Completed Protocols (Information Regarding these protocols may be found in the Reference List)

  • A Phase I/II Trial of BMS-247550 for Treatment of Patients with Recurrent High Grade Gliomas
  • Phase I/II Clinical and Pharmacologic Study of 9-Amino-20(S)-Camptothecin (9-AC) Administered as a 72 Hours Infusion in Adults with Recurrent or Progressive Malignant Glioma
  • Phase II Study of Suramin in the Treatment of Recurrent or Progressive Malignant Glioma
  • Phase II Study of ISIS 3521 in Adults with Recurrent Malignant Gliomas
  • Phase I/II Evaluation of Phenylbutyrate in Adults with Recurrent Malignant Gliomas
  • Phase I/II Trial of CPT-11 in Adults with Recurrent Malignant Gliomas
  • A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
  • A Phase I/II Trial of EMD 121974 for Treatment of Patients with Recurrent Anaplastic Gliomas
  • A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients with High Grade Astrocytoma
  • A Phase I/II Trial of MGI-114 for Treatment of Patients with Recurrent Malignant Gliomas
  • A Phase I Evaluation of the Safety and Pharmacokinetics of Atrasentan in Adults with Recurrent Malignant Gliomas
  • Phase I Evaluation of the Safety of Karenitecin in Treatment of Recurrent Malignant Gliomas
  • A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered with Fixed Dose of BCNU Every 6 weeks in Patients with Recurrent Glioblastoma Multiforme

CLASS D

• Active Protocol

  • An Open-label, Dose Confirmation and Dosimetry Study of Interstitial ¹³¹I-chTNT-1/B MAb (COTARA^TM) For the Treatment of Glioblastoma Multiforme (GBM) at 1^st or 2^nd Relapse

• Protocols In Development (Expanded Information Not Available)

  • None currently

• Completed Protocols (Information Regarding these protocols may be found in the Reference List)

  • Phase I Gliadel and Escalating Doses of Intravenous O6-Benzylguanine Trial in Patients with Recurrent Malignant Gliomas
  • Phase I Dose Escalation Study of Gliadel in Adults with Recurrent Malignant Gliomas
  • A Multi-center, Open Label Clinical Study to Evaluate the Safety and Performance of the Proxima Gliasite RTS, A Radiation Delivery System, in Patients with Recurrent Malignant Brain Tumors Undergoing Surgical Resection

  • A Phase I, Open-Label, Dose Escalation, Trial of Intratumoral Injection with an ETB-Attenuated Adenovirus (Active and UV-Inactivated), Onyx-015, into Recurrent Malignant Gliomas

  • Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. Gliasite RTS in Patients with Recurrent Malignant Gliomas
  • Phase I Brachytherapy Dose Escalation Using the GliaSite RTS in Newly Diagnosed Glioblastoma Multiforme in Conjunction with External Beam Radiation Therapy.
  • Interstitial Infusion of IL13-Pe38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
  • A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

CLASS E

• Active Protocols

  • A Phase II Study of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy for Patients with Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)

• Protocols In Development (Expanded Information Not Available)

  • None currently

• Completed Protocols (Information Regarding these protocols may be found in the Reference List)

  • A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients with Newly Diagnosed Primary CNS Lymphoma
  • Phase II Study of High Dose Systemic Methotrexate in Adults with Primary Central Nervous System Lymphoma
  • The Treatment of One or Two Supratentorial Brain Metastases with Surgical Resection and BCNU-Polymer Wafers

CLASS F

• Active Protocol

  • A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas
  • CD4 Count and Risk of Infection in Patients with Brain Tumors
  • Pilot Study of Thrombophilic States in Patients with High-Grade Gliomas
  • Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation with Magnetic Resonance Imaging Findings

• Protocols In Development (Expanded Information Not Available)

  • None currently

• Completed Protocols (Information Regarding these protocols may be found in the Reference List)

  • A Randomized, Placebo Controlled Trial of Warfarin for the Prevention of Thromboembolic Events in Glioma Patients