Adult Protocols

Updated 8/16/04

Consortiums
NABTT: New Approaches Brain Tumor Therapy
ACoSOG: American College of Surgeons Oncology Group
BBBD: Blood Brain Barrier Disruption
RTOG: Radiation Therapy Oncology Group
SWOG: South West Oncology Group
COG: Children's Oncology Group

Gliomas

IL13-PE38QQR infusion followed by RT +/- Temozolomide (IL13PEI-106)
Description: A Phase I Study of Convection Enhanced Delivery (CED) of IL 13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients with Newly Diagnosed Supratentorial Malignant Glioma.
Eligibility: Patients must be 18 years old with a malignant glioma & have had a gross total resection of solid contrast-enhancing lesion (s) > 1.0 cm in diameter. Must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection). Contact investigator for additional eligibility criteria.
Study Design: Phase I internal study.
Contact: Michael Vogelbaum, MD, PHD, at 216-444-8564

Temozolomide with radiation therapy against hard-to-treat high-grade gliomal brain tumors.
Description: A Phase II Study of Temozolomide in the Treatment of Children with High-Grade Gliomas.
Eligibility: Patients must be > 3 years of age & < 22 years of age at time of enrollment. Histologic confirmed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma. Patients with primary spinal cord malignant gliomas are also eligible. Metastatic disease--ineligible.
Study Design: Phase II. Initially patients receive temozolomide concurrently with radiation therapy on 42-day schedule. 4 weeks after radiation therapy, patients receive temozolomide daily for 5 days, beginning a new cycle every 28 days; 10 cycles total.
Contact: Joanne M. Hilden, MD 216-444-8407

IL13-PE38QQR & Gliadel ® Wafer (PRECISE)
Description: A Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE3QQR Compared to Gliadel ® Wafer with Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence.
Eligibility: Patients must be > 18 years old & have clinical or radigraphic evidence of recurrent or progressive supratentorial tumor, histopathologic documentation of GBM at initial diagnosis, previous cytoreductive surgery or biopsy for GBM & must have received external beam radiotherapy completed > 4 weeks prior to study entry.
Study Design: Phase III internal study.
Contact: Gene H. Barnett, M.D. 216-444-5381

Erlotinib with Temozolomide & Radiation for Newly Diagnosed GBM's
Description: A Phase II Trial of Erlotinib with Temozolomide & Concurrent Radiation Therapy Post-operatively in Patients with Newly Diagnosed Glioblastoma Multiforme
Eligibility: Newly diagnosed glioblastoma multiforme, >= 18 years old.
Study Design: Phase II internal study
Contact: David Peereboom, M.D. 216-445-6068

R115777 for Newly Diagnosed GBM's
Description: Phase II Study of R115777 for the Treatment of Adults with Newly Diagnosed Glioblastoma Multiforme (NABTT 2200)
Eligibility: Histologically confirmed supratentorial grade IV astrocytoma (GBM), no prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy) or hormonal therapy for their brain tumor. Glucocorticoid therapy is allowed.
Study Design: Phase II cooperative group study
Contact: David Peereboom, M.D. 216-445-6068

Radiation therapy & Temozolomide for Anaplastic Oligodendrogliomas & Mixed Anaplastic Oligoastrocytomas
Description: A Phase II Trial of PreIrradiation & Concurrent Temozolomide in Patients with Newly Diagnsosed Anaplastic Oligodendrogiomas & Mixed Anaplastic Oligoastrocytoma (RTOG 0131)
Eligibility: Pathologic evidence of unifocal or multifocal supratentorial pure or mixed anaplastic oligodendroglioma. Age ³ 18.
Study Design: Phase II cooperative group study
Contact: John Suh, M.D. 216-444-5574

Celecoxib & Anticonvulsants for Newly Diagnosed GBM's undergoing Radiation Therapy
Description: A Pharmacokinetic Study of the Interaction between Celecoxib & Anticonvulsant Drugs in Patients with Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy (NABTT 2100)
Eligibility: Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme). Age ³ 18.
Study Design: Pharmacokinetic cooperative group study
Contact: Glen Stevens, D.O., Ph.D. 216-445-1787

Atrasentan for Recurrent Malignant Gliomas
Description: A Phase I Evaluation of the Safety & Pharmacokinetics of Atrasentan in Adults with Recurrent Malignant Gliomas (NABTT 2008)
Eligibility: Histologically proven malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme. Age ³ 18.
Study Design: Phase I cooperative group study
Contact: David Peereboom, M.D. 216-445-6068

Tarceva (Recurrent/Progressive Glioblastoma Multiforme)
Description: A Phase II study of OSI-744 used alone in patients with recurrent malignant gliomas.
Eligibility: Patients must be at least 18 years of age and have Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme), with radiographic evidence of recurrence.
Study Design: Internal, phase II
Contact: Michael Vogelbaum, M.D., Ph.D. 216-444-8564

AOCOSG Z0300 (One to three Cerebral Metastases)
Description: A Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in the Management of Patients with One to three Cerebral Metastases
Eligibility: Patient must be at least 18 years of age
Study Design: ACOSOG Consortium, phase III
Contact: Michael Vogelbaum, M.D., Ph.D. 216-444-8564

Arsenic (Newly Diagnosed Glioblastoma Multiforme)
Description: Phase I Study of Combined Radiotherapy and Arsenic Trioxide for the Treatment of Newly Diagnosed Malignant Glioma (NABTT 2115)
Eligibility: Patients must be at least 18 years of age and have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme).
Study Design: NABTT consortium, phase I
Contact: John Suh, M.D. 216-444-5574

BMS (Recurrent Malignant Glioma)
Description: A Phase I/II Study of BMS-24755A Phase I/II Study of BMS-247550 for Treatment of Patients with Recurrent Malignant Gliomas (NABTT 2111)
Eligibility: Patients must be 18 years of age or older and have histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme) which is progressive or recurrent following radiation therapy ± chemotherapy. Patients with previous low grade glioma who progressed after radiotherapy +/- chemotherapy and are biopsied and found to have a high grade glioma are eligible.
Study Design: NABTT consortium, phase I/II
Contact: David Peereboom, M.D. 216-445-6068

NABTT 2006 (Oxaliplatin for Newly Diagnosed Glioblastoma Multiforme)
Description: Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults with Newly Diagnosed Glioblastoma Multiforme
Eligibility: Patients must be at least 18 years of age and have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme).
Study Design: NABTT consortium, phase I/II
Contact: David Peereboom, M.D. 216-445-6068

Karenitecin (Recurrent Malignant Gliomas)
Description: Phase I Evaluation of the Safety of Karenitecin in the Treatment of Recurrent Malignant Gliomas NABTT 2006
Eligibility: Patients must be 18 years of age or older and have histologically proven malignant glioma (anaplastic astrocytoma, anaplastic oliogodendroglioma or glioblastoma multiforme) which is progressive or recurrent following radiation therapy +/-chemotherapy. Patients with previous low grade glioma who progressed after radiotherapy +/- chemotherapy and are biopsied and found to have a high grade glioma are eligible.
Study Design: NABTT consortium, phase I
Contact: David Peereboom, M.D. 216-445-6068

Blood Brain Barrier Disruption (Anaplastic Oligodendroglioma, Anaplastic Astrocytoma)
Description: chemotherapy administered via blood brain barrier disruption
Study Design: Internal study. Phase II multi-institutional trial
Eligibility: Age 18-75
Contact: Gene H Barnett, MD, 216 444-5381

Tamoxifen-Hypothyroid GBM
Description: High-dose Tamoxifen in combination with reduction of thyroid hormone during and post external beam radiotherapy.
Study Design: Internal study: phase II
Eligibility: Newly diagnosed GBM, Age >18yrs
Contact: John Suh, MD, 216 444-5574

RTOG-9813 (Anaplastic Astrocytoma)
Description: Radiation with randomization to one of three chemotherapy options
Study Design: RTOG-98-13, Phase I/III trial
Eligibility: Anaplastic astocytoma, Age 18yrs
Contact: John Suh, MD, 216 444-5574

NABTT 9806
Description: A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered with a Fixed Dose of BCNU Every Six Weeks in Patients with Recurrent Malignant Glioma
Study Design: Phase I/II
Eligibility: Patients must have progressive or recurrent malignant glioma, must have previously received radiation therapy with the last fraction administered at least 90 days prior to Day 1 of Cycle 1, and must have had no prior treatment for gliomas with nitrosoureas and must not have received more than one chemotherapy regimen, with the last dose of chemotherapy administered at least 4 weeks prior to Day 1 of Cycle 1.
Contact: David Peereboom, M.D. 216-445-6068

NABTT 9903 (IL-13PE38QQR high grade gliomas)
Description: Interstitial infusion of IL 13-PE38QQR for recurrent high grade gliomas
Study Design: NABTT, Phase I/II study
Eligibility: Biopsy proven recurrent high grade glioma, age >18rs
Contact: Gene H Barnett, MD, 216 444-5381

SWOG S0001: Upfront Treatment for Newly Diagnosed GBMs
Description: Randomization to Radiation therapy + O6-BG + BCNU vs Radiation + BCNU Alone
Study Design: Phase III SWOG study
Eligibility: Newly diagnosed GBM, KPS >60
Contact: David Peereboom, MD, 216 445-6068

Miscellaneous
S100
PLA CNS

Blood Brain Barrier Disruption (CNS Germ Cell)
Description: Chemotherapy administered via blood brain barrier disruption
Study Design: Phase II, Multi-Institutional trial
Eligibility: CNS germ cell, Age 18-75
Contact: Gene H Barnett, MD, 216 444-5381

Medulloblastoma, PNET, and Ependymoma

Blood Brain Barrier Disruption (Medulloblastoma and PNET)
Description: Chemotherapy administered via blood brain barrier disruption
Study Design: Phase II. Multi-Institutional trial
Eligibility: Medulloblastoma or PNET, Age 18-75
Contact: Gene H Barnett 216 444-5381

Lymphoma

Blood Brain Barrier Disruption (Primary Central Nervous System Lymphoma)
Description: Phase II Study for Patients with Relapsed Primary Central Nervous System Lymphoma
Eligibility: Patients must be 18-75 yrs of age histologically confirmed Primary CNS Lymphoma as documented by brain biopsy, or cytology (analysis
from CSF or vitrectomy), & CD20 positive.
Study Design: Internal, phase II
Contact: Glen Stevens, DO., PhD. (216) 445-1787

Blood Brain Barrier Disruption (Primary central nervous system lymphoma)
Description: Chemotherapy administered via blood brain barrier disruption
Study Design: Phase II, Multi-Institutional trial
Eligibility: Primary CNS lymphoma, Age 16-75 yrs
Contact: Gene H Barnett, MD, 216 444-5381

Combination oral & intravenous chemotherapy (Primary central nervous system lymphoma)
Description: Combination oral and intravenous chemotherapy
Study Design: Phase II, Multi-Institutional trial
Eligibility: Primary CNS lymphoma, Age 16-75 yrs
Contact: Gene H Barnett, MD, 216 444-5381

Phase 2 Trial of adults with progressive, persistent of recurrent meningioma with temodar
Description: Chemotherapy with temozolomide
Study Design: phase II, multicenter
Eligibility: Progressive, persistent, or recurrent meningioma. Age >18yrs
Contact: David Peereboom, MD, 216 445-6068

SWOG-9811 (Benign Meningioma)
Description: Chemotherapy with hydroxyurea
Study Design: phase II, cooperative group
Eligibility: Primary, recurrent or residual benign meningioma which is unresectable, Age >18yrs, XRT > 1 yr
Contact: David Peereboom, MD, 216 445-6068

Metastases

Zeiss INTRABEAM System for Intraoperative Radiotherapy of Newly Diagnosed Supratentorial Brain Metastasis
Description: The Zeiss Intrabeam system is an intraoperative radiotherapy system that combines the advantages of external beam radiosurgery with those of brachytherapy (implantation of radiation seeds).
Eligibility: Patients must be 18 years old, must have a newly diagnosed supratentorial single metastatic brain tumor as visualized on enhanced MRI scan that is surgically resectable, must have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report. KPS >= 70 & life expectancy of at least 3 months.
Study Design: Phase I/II internal trial.
Contact: Steven Toms, MD, MPH, at 216-445-7303

AOCOSG Z0300 (One to three cerebral metastases)
Description: A Phase III Multicenter Trial comparing Surgery with Whole Brain Irradiation Versus Stereotactic Radiosurgery Boost with Whole Brain Irradiation for Patients with Single Brain Metastasis
Study Design: Multicenter trial phase III
Eligibility: Single brain metastases that can be surgically resected, No previous cranial radiation.
Contact: Gene Barnett, M.D. 216-444-5381

Blood Brain Barrier Disruption (Metastatic breast or lung)
Description: Intra-arterial chemotherapy administered with or without blood brain barrier disruption
Study Design: Phase II. Multi-Institutional trial
Eligibility: Metastatic breast or lung, Age 18-75 yrs
Contact: Gene H Barnett, MD, 216 444-5381

GliaSite for Brain Metastases
Description: Newly diagnosed single supratentorial brain metastasis that is surgically resectable. Uses Gliasite Radiation Therapy System
Study Design: Phase II Multi-institutional study
Eligibility: Newly diagnosed single surgically resected brain metastasis without prior history of cranial irradiation, Age > 18yrs
Contact: Mike Vogelbaum, MD, 216 444-5381

Gamma Knife for Brain Metastases
Description: Newly diagnosed single supratentorial brain metastesis treated with stereotactic radiosurgery and whole brain radiation vs surgical resection followed by whole brain radiation.
Study Design: Internal Study
Eligibility: Newly diagnosed single supratentorial brain metastesis without prior brain irradiation
Contact: Gene H Barnett, MD, 216 444 5381

Xcytrin for Non-Small Cell Lung Cancer Brain Metastases
Description: Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injections for the Treatment of Brain Metastases in Patients with Non-Small
Cell Lung Cancer Undergoing Whole Brain Radiation Therapy.
Study Design: Phase III Randomized trial
Eligibility: Non-small cell lung cancer with brain metastases
Contact: John Suh, M.D. 216-444-5574

Cyberknife Radiosurgery (Primary tumors or metastases)
Description: Clinical evaluation of the cyberknife radiosurgery platform
Study Design: Investigational Device Exemption
Eligibility: Adults with benign or malignant tumors of the brain and metastatic brain tumors
Contact: Richard L Crownover, PhD, MD, 216 444-1925