Brain Tumor Treatment Protocols
Brain tumor therapy research protocols currently offered at Wake Forest University School of Medicine are listed. Treatments for all types of tumors are also available off-protocol. Wake Forest University School of Medicine of is an NIH designated Comprehensive Cancer Center. We are a member of the National Cancer Institute's New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium. Also see additional sources of information about specific tumor types in the menus to the left.
Recurrent/progressive high grade astrocytoma/glioblastoma protocols
- The PRECISE Trial: IL13-PE38QQR vs. Gliadel at first recurrence of glioblastoma multiforme.
- To find out about eligibility for the PRECISE Trial at Wake Forest University Neurosurgery in Winston-Salem, NC USA please call 1-336-716-4031 or email chmiller@wfubmc.edu.
- Follow the link above for information about enrollment at other sites.
- Gliasite RTS: Due to the results of the recent NABTT Gliasite protocol Gliasite RTS received FDA approval and is now available "off-protocol" for the treatment of malignant brain tumors.
NABTT 98-01 Phase I, Open-Label Dose Escalation to with Gene Therapy using an E1B-attenuated Adenovirus, Onyx-015 into Recurrent Malignant Brain Tumors Undergoing Surgical Resection.
Treatment
ONYX-015 placed in resection cavity.
Pretreatment Evaluations
Neuro eval, KPS, brief medical history, MRI.
Eligibility
Follow-up only. No longer adding new patients.
NABTT 98-03 IL-13 pseudomonas exotoxin: Phase I, Escalating Doses of Intratumoral IL-13 pseudomonas exotoxin in People with Recurrent Malignant Glioma.
Treatment IL-13 pseudomonas exotoxin by positive-pressure intratumoral infusion for four days after surgery (stereotactic tumor biopsy).
Pretreatment Evaluations
As outlined in protocol.
Eligibility
Biopsy otherwise indicated, for recurrent supratentorial brain tumor (recurrent glioma).
NABTT 98-03 O6-BG: Phase I, Gliadel® & Escalating Doses of Intravenous O6-Benzylguanine in People with Recurrent Malignant Glioma
Treatment O6-BG by vein for fourteen days after surgery and placement of BCNU-releasing wafers.
Pretreatment Evaluations (<2 weeks prior to tumor resection )
As outlined in protocol.
Eligibility
Cytoreductive surgery for removal of unilateral, supratentorial brain tumor (recurrent glioma).
NABTT 99-01 A Phase I/II study of oral procarbazine in treatment of recurrent high grade astrocytoma
Treatment
Procarbazine 200mg/m2 Xmg/wk x 5 days q 4weeks until progression.
Pretreatment Evaluations
Neuro eval, KPS, MRI or CT, ECG, CXR, labs, u/a.
Eligibility
KPS > 60; Age > 18 yrs.
measurable progressive / recurrent malignant glioma.
NABTT 97-11 A Dose Finding and Safety/Efficacy Trial of CPT-11 (Irinotecan) in Patients with Recurrent Malignant Gliomas
Treatment
Starting at 125mg/m2 Xmg/wk x 4 wks followed by 2 wk break until progression.
Pretreatment Evaluations
Volumetric scan.
Eligibility
KPS > 60; Age > 18 yrs.
Histologic proof of progressive or recurrent malignant glioma.
NABTT 99-11 A Dose Finding and Safety/Efficacy Trial of EMD 121974 in Patients with Recurrent Malignant Gliomas
Treatment
One hour infusion once a day two times a week for 4 weeks per cycle. MRI every other cycle.
Pretreatment Evaluations
MRI. PICC line.
Eligibility
KPS > 60; Age > 18 yrs.
Progressive or recurrent malignant glioma.
NABTT 98-09 A Phase I/II Trial of Col-3 on a Continuous Daily Oral Schedule in Patients with Recurrent Malignant Gliomas
Treatment
Oral, daily drug. MRI every four weeks.
Pretreatment Evaluations
MRI.
Eligibility
KPS > 60; Age > 18 yrs.
Progressive or recurrent malignant glioma.
Newly diagnosed glioblastoma multiforme/malignant glioma protocols
Gliasite RTS: Due to the results of the recent NABTT Gliasite protocol conducted at Wake Forest Gliasite RTS recieved FDA approval and is now available "off-protocol" for the treatment of malignant brain tumors.
Click here for more information on Gliasite RTS treatment at the Wake Forest Brain Tumor Center.
NABTT PZA: Phase I/II Study of Pyrazoloacridine (PZA) in Adults
with Newly Diagnosed Glioblastoma Multiforme.
Treatment
Chemotx by vein for up to 4 months. Radiation therapy is given after chemotherapy.
Pretreatment evaluations
Post-operative (or post-biopsy) MRI demonstrating measurable, residual, enhancing disease.
Eligibility
KPS > 60; Age > 18 yrs;
Histologic confirmation of supratentorial GBM. No prior RT or chemo.
NABTT Oxiliplatin: Phase I/II trial of Oxiliplatin as Neoadjuvant Treatment in Adults with Newly Diagnosed GBM
Treatment
Chemotx by vein over 2 hours once every fourteen days repeated up to six times. Radiation therapy is given after chemotherapy.
Pretreatment evaluations
Post-operative (or post-biopsy) MRI demonstrating measurable, residual, enhancing disease.
Eligibility
KPS > 60; Age > 18 yrs;
Histologic confirmation of supratentorial GBM. No prior RT or chemo.
CCCWFU 91396 (CCTC 98-01) Phase I Dose Escalation Study of RT Using 3-Dimensional Treatment Planning for Newly Diagnosed GBM
Treatment
Dose escalation of RT based on Recursive Partitioning Analysis (RPA) class
Pretreatment evaluations
See Protocol.
Eligibility
KPS > 70; Age > 18 yrs;
Histologic confirmation of supratentorial non-optic location GBM.
CCCWFU 91A97 Bio-Anatomic Radiation Treatment Planning
Treatment
Pre-treatment CT/MRI/PET Hypoxia scan.
Pretreatment evaluations
See Protocol.
Eligibility
Histologic confirmation of GBM.
RTOG 98-03 Phase I/II Radiation Dose Escalation Study Applying Conformal Therapy for Supratentorial GBM
Treatment
Arm 1: RT + BCNU
Arm 2: Radiosurgery followed by RT + BCNU
Pretreatment Evaluations
CT/MRI +/- contrast pre and post op.
Eligibility
Study tx to begin < 5 weeks of surgery.
Post-op enhancing tumor < 40 mm.
CCCWFU 97898 The Effect of Methylphenidate on Neurobehavioral Slowing and Quality of Life in Patients with Metastatic or Primary Brain Tumors Recieving Radiation Therapy
Treatment
methylphenidate (Ritalin®) 10 mg bid dose escalation q5-7 days up to 30mg bid.
Pre-treatment Evaluations
Various quality of life and mental status tests as outlined in the protocol.
Eligibility
KPS>60; Age>18 yrs; No prior cranial RT.
RTOG 98-13 A Phase I/III Randomized Trial of Radiation Therapy and Temozolomide versus Radiation Therapy and BCNU versus Radiation Therapy and BCNU and Temozolomide for Anaplastic Astrocytoma.
Treatment
Intravenous drug and radiation therapy.
Pretreatment Evaluations
MRI.
Eligibility
KPS > 60; Age > 18 yrs.
Newly diagnosed anaplastic astrocytoma.
Newly diagnosed low grade glioma
Oligodendroglioma
RTOG 94-02 Phase III Intergroup Randomized Comparison of RT Alone vs Pre-RT Chemo for Pure and Mixed Anaplastic Oligodendrogliomas
Treatment
Arm 1: CCNU, Vincristine, Procarbazine followed by RT.
Arm 2: RT alone.
Pretreatment Evaluations
CXR; PFTs as indicated; CT/MRI +/- contrast.
Eligibility
Supratentorial (not posterior fossa) pure or mixed anaplastic oligodendrogliomas
confirmed by central pathology review.
Randomization must take place < 8 wks of surgery/tissue diagnosis.
No prior RT or chemo. Disease free of prior malignancies >5 yrs.
Astrocytoma, oligodendroglioma, and mixed oligoastrocytoma
RTOG 98-02 Phase II Study of Observation in Favorable Low-Grade Glioma and Phase III Study of RT +/- PCV Chemo in Unfavorable Low-Grade Glioma
Treatment
Arm 1: (Low risk; <40 yrs of age undergoing gross total resection of a WHO grade II astrocytoma, oligodendroglioma, or mixed oligoastrocytoma) Observe postoperatively.
Arm 2: (High risk; >40 yrs old regardless of degree of surgical resection, or age >18 yrs undergoing subtotal resection or biopsy of WHO grade II astrocytoma, oligodendroglioma, or oligoastrocytoma) post-op RT alone.
Arm 3: (High risk; >40 yrs old regardless of degree of surgical resection, or age >18 yrs undergoing subtotal resection or bx of WHO grade II astrocytoma, oligodendroglioma, or oligoastrocytoma) post-op RT + PCV x 6 cycles.
Pretreatment Evaluations
Central path review pre-randomization; MRI +/- contrast pre and post op; Mini-mental status exam.
Eligibility
Histologic proof of supratentorial WHO grade II astrocytoma, oligodendroglioma, oligoastrocytoma; KPS >60; NFS <3;Age >18 yrs.
CCCWFU 97898 The Effect of Methylphenidate on Neurobehavioral Slowing and Quality of Life in Patients with Metastatic or Primary Brain Tumors Recieving Radiation Therapy
Treatment
methylphenidate (Ritalin®) 10 mg bid dose escalation q5-7 days up to 30mg bid.
Pre-treatment Evaluations
Various quality of life and mental status tests as outlined in the protocol.
Eligibility
KPS>60; Age>18 yrs; No prior cranial RT.
Brain metastases
Gamma Knife Radiosurgery is one of the most successful treatments for most brain metastases. In 90% of eligible patients it achieves local control of lesions in the brain.
Click here for more information on Gamma Knife Radiosurgery treatment for brain metastases at the Wake Forest Brain Tumor Center.
ACOSOG Z-0300 is a study available at Wake Forest comparing Gamma Knife plus whole brain radiation versus Gamma Knife alone for the treatment of 1-3 brain metastases.
Gliasite RTS: Due to the results of the recent NABTT Gliasite protocol Gliasite RTS recieved FDA approval and is now available "off-protocol" for the treatment of malignant brain tumors.
Click here for more information on Gliasite RTS treatment at the Wake Forest Brain Tumor Center.
The opportunity to participate in a trial of GliaSite RTS for people with one-three brain metastases is also available.
CCCWFU 91297 Phase II Study to Evaluate the Efficacy and Safety of Repetitive Daily IV Doses of RSR13 Administered to Patients Receiving Cranial RT for Brain Metastases
Treatment Dosing qd with RSR13 < 30 mins prior to RT (10 fractions).
Pretreatment Evaluations (<2 weeks prior to initial study drug administration)
As outlined in protocol.
Eligibility
Weight less than 264 lbs. KPS>70. Age>18. Resting oxygen saturation>90% on room air. Breat or non-small cell lung primary with hjistological, cytological, or radiographic conformation of brain metastases.
CCCWFU 91196 Phase Ib-II: Repetitive Dose Trial of Gadolinium Texaphyrin (PCI-0120) Injection as a Radiosensitizer in Patients with Metastatic Cancer to the Brain.
Treatment
Gadolinium Texaphyrin (PCI-0120) iv before each fraction of RT for a minimum of 10 doses
Pretreatment Evaluations
CXR; ECG; MRI/CT for sites and measurements
Eligibility For max tolerated dose phase, unresected brain mets demonstrated by imaging, requiring palliative radiation.
No plans for chemotherapy during 14 day follow-up.
RTOG 95-08 Phase III Trial Comparing Whole Brain Irradiation With vs Without Stereotactic Radiosurgery Boost for Pts with One to Three Unresected Brain Mets.
Treatment
Arm 1: Whole brain RT followed by SRS to all 1-3 mets.
Arm 2: Whole brain RT alone.
Pretreatment evaluations
Brain MRI. Bone scan and CT chest/abd/pelvis strongly recommended.
Eligibility
Histologically confirmed systemic malignancy with one to three unresected brain mets.
No prior cranial RT.
CCCWFU 97898 The Effect of Methylphenidate on Neurobehavioral Slowing and Quality of Life in Patients with Metastatic or Primary Brain Tumors Recieving Radiation Therapy
Treatment
methylphenidate (Ritalin®) 10 mg bid dose escalation q5-7 days up to 30mg bid.
Pre-treatment Evaluations
Various quality of life and mental status tests as outlined in the protocol.
Eligibility
KPS>60; Age>18 yrs; No prior cranial RT.
CNS Lymphoma
RTOG 93-10 An Intergroup Phase II Combined Modality Treatment of Primary Central Nervous System Lymphoma.
Treatment
Methotrexate, Procarbazine, Vincristine, and intra-Ommaya Methotrexate over 10 weeks followed by whole brain RT.
Pretreatment evaluations
Labs, CXR, CT/MRI histologic confirmation of non-Hodgkin's lymphoma.
Eligibility
KPS > 50; Age > 18 yrs. Registered < 4 weeks from histologic diagnosis. HIV negative.
Neoplastic (carcinomatous) meningitis
CCCWFU 91296 Phase IV Multi-center Clinical Study of DepofoamTM Encapsulated Cytarabine (DTC101) in the Tx of Neoplastic Meningitis in Pts with Solid Tumors, Including Primary Brain Tumors.
Treatment Lumbar or intraventricular tx with DTC 101.
Pretreatment evaluations
CSF flow studies as described in protocol.
Eligibility
Solid tumors, including primary brain tumors, but excluding lymphomas and leukemias.
Pediatric Brain Tumor Protocols
POG 9432 A Phase II Study of Pre-RT Topotecan in Newly Diagnosed Children with Intracranial Ependymoma.
Treatment
Initial Surgery, Topotecan x 3 courses, then MRI, then EBRT or SRS.
Pretreatment evaluation
Labs, Pre/Post-op MRI, MRI spine, CSF, Audiogram.
Eligibility
Age > 36 mo; < 21 yrs. No prior treatment.
POG A9961 A Phase III Prospective Randomized Study of Craniospinal RT Followed by One of Two Adjuvant Chemotherapy Regimens (CCNU/CDDP/VCR vs CPM/CDDP/VCR) in Children with Newly Diagnosed Average-Risk Medulloblastoma.
Treatment
VCR + craniospinal RT, then Regimen A or B in 8 courses.
Pretreatment evaluations
Labs, MRI Head/Spine, CSF, Audiometric Evaluation, Echo, PFTs.
Eligibility
Age > 3 yrs; < 21 yrs at time of diagnosis.
POG 9631 Phase II Feasibility Study of Oral Etoposide Given Concurrently with Radiotherapy Followed with Dose Intensive Adjuvant Chemotherapy for Children with Newly Diagnosed High-Stage Medulloblastoma.
Treatment
6 wks of RT to head and spine + boosts to posterior fossa and to sites of mets if present with concurrent daily Etoposide.
Eligibility
Age > 3 and < 21 yrs; presence of advanced medulloblastoma as defined by protocol.
Brain Tumor Protocol Coordinators at Baptist Hospital/Wake Forest Comprehensive Cancer Center
Radiation Oncology RTOG
Lisa Gallaher, RN (336) 716-9321
June Fletcher-Steele (336) 716-6733
Donella Edwards Protocol Specialist (336) 713-6912
Medical Oncology NABTT; CCCWFU
Michelle Harmon, RN (336) 713-9625
Martha Culbreth, RN (336) 716-9321
Neurosurgery
Charlotte Miller, RN (336) 716-4031 email: chmiller@wfubmc.edu
Joyce Moser, RNP (336) 716-4047 email: jamoser@wfubmc.edu
Pediatric Oncology POG
Kathi Dale, CRA (336) 716-2748
Joy Mitchell, CRA (336) 716-7045
Glossary
Abbreviations
RTOG= Radiation Therapy Oncology Group
NABTT= New Approaches to Brain Tumor Therapy
CCCWFU= Comprehensive Cancer Center of Wake Forest University
+ with
- without
EBRT External Beam Radiation Therapy
SRS Stereotactic Radiosurgery
KPS Karnofsky Performance Status
ECOG Eastern Cooperative Oncology Group (performance status)
Karnofsky | Performance Status | ECOG |
100 | Normal; no complaints; no evidence of disease. | 0 |
90 | Able to carry on normal activity; minor signs or symptoms of disease. | 0 |
80 | Normal activity with effort; some signs or symptoms of disease. | 1 |
70 | Cares for self; unable to carry on normal activity or do active work. | 1 |
60 | Requires occasional assistance, but is able to care for most personal needs. | 2 |
50 | Requires considerable assistance and frequent medical care. | 2 |
40 | Disabled; requires special care and assistance. | 3 |
30 | Severely disabled; hospitalization is indicated, although death not .imminent | 3 |
20 | Very sick; hospitalization necessary; active support treatment is necessary. | 4 |
10 | Moribund; fatal processes progressing rapidly. | 4 |
0 | Dead. | 4 |