Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00621686
Other study ID # NCCTG-N0776
Secondary ID NCI-2009-00832CD
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2008
Est. completion date February 19, 2014

Study information

Verified date April 2018
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with sorafenib works in treating patients with recurrent glioblastoma multiforme.


Description:

OBJECTIVES:

Primary

- Identify the clinical efficacy of bevacizumab and sorafenib, as measured by 6-month progression-free survival, in patients with recurrent glioblastoma multiforme.

Secondary

- Assess time to progression of this patient population.

- Assess overall survival of this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib once daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and plasma sample collection at baseline and then periodically during study treatment for translational research studies. Translational research studies include analysis of circulating endothelial cells and circulating endothelial progenitor cells by flow cytometry and measurement of angiogenic proteins in plasma by ELISA. DNA and buffy coat are extracted and collected from the blood samples for pharmacogenetic studies.

Quality of life is assessed at baseline, prior to every other treatment course, and at the end of treatment.

After completion of study treatment, patients are followed at 28-42 days, every 3 months for 5 years, and then annually for 10 years.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date February 19, 2014
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review

- Gliosarcoma allowed

- Must have evidence of tumor progression by MRI or CT scan following radiotherapy or the most recent anti-tumor therapy

- No more than 1 chemotherapy regimen for progressive or recurrent disease

- Bidimensionally measurable or evaluable disease by MRI or CT scan

- No evidence of CNS hemorrhage on baseline CT or MRI

- Patients with T1 hyperintensity confined to the surgical cavity which is felt likely due to post surgical blood contaminating the intracavity cerebrospinal fluid or irrigation that have not yet absorbed and which is not felt to clinically or radiographically represent new spontaneous hemorrhage are eligible

- Patients with old blood products or hemosiderin without a history of spontaneous bleeding are eligible

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC = 1,500/mm³

- Platelet count = 100,000/mm³

- Hemoglobin > 9.0 g/dL

- Total bilirubin = 1.5 times upper limit of normal

- AST = 3 times upper limit of normal

- Creatinine = upper limit of normal

- Urine protein:creatinine ratio < 1 OR urine protein < 1,000 mg by 24-hour urine collection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for six months after completion of study treatment

- Able to complete questionnaire(s) alone or with assistance

- Willing to return to NCCTG enrolling institution for follow-up

- Willing to provide mandatory blood samples for research purposes

- Not immunocompromised (other than that related to the use of corticosteroids)

- No known HIV positivity

- No concurrent uncontrolled illness including, but not limited to, the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study requirements

- No inadequately controlled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg while on antihypertensive medications)

- Patients with well-controlled hypertension are eligible

- No myocardial infarction or unstable angina within the past 6 months

- No congestive heart failure requiring the use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

- No New York Heart Association class II-IV congestive heart failure

- No significant vascular disease (e.g., aortic aneurysm or aortic dissection)

- No peripheral arterial thrombosis within the past 6 months

- No stroke or transient ischemic attack within the past 6 months

- No history of hypertensive crisis or hypertensive encephalopathy

- No evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)

- No active or recent history of hemoptysis (i.e., = ½ teaspoon of bright red blood per episode) within the past 30 days

- No serious, nonhealing wounds, ulcers, or bone fractures

- No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation)

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

- No significant traumatic injury within the past 28 days

- No known hypersensitivity to any of the components of sorafenib or bevacizumab

- No other active malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the cervix

- Patients with a history of prior malignancy must not be receiving specific treatment (other than hormonal therapy) for that malignancy

- No co-morbid systemic illness or other concurrent severe disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or significantly interfere with the proper assessment of safety and toxicity of the prescribed study regimen

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 12 weeks since prior radiotherapy

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- More than 2 weeks since prior small molecule cell cycle inhibitors

- At least 1 week since prior fixed-dose corticosteroids (or no corticosteroids)

- No prior intratumoral chemotherapy, stereotactic radiosurgery or interstitial brachytherapy unless there is a separate lesion on MRI that is not part of the prior treatment field OR there is proof of recurrent disease based on biopsy, MRI spectroscopy, or PET scan

- No prior antiangiogenic therapy

- No prior surgical procedures affecting absorption

- More than 7 days since prior core biopsy or other minor surgical procedures

- Placement of a vascular access device is allowed

- More than 28 days since prior major surgical procedure or open biopsy

- No concurrent major surgical procedure

- No other concurrent investigational agents

- No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone)

- No other concurrent potent CYP3A4 inducers (e.g., rifampin or St. John's wort)

- No concurrent therapeutic anticoagulation with warfarin

- Prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided the INR < 1.5

- Therapeutic anticoagulation with low molecular weight heparin allowed

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
bevacizumab

Drug:
sorafenib tosylate


Locations

Country Name City State
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States McFarland Clinic, PC Ames Iowa
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States Rush-Copley Cancer Care Center Aurora Illinois
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States MeritCare Bemidji Bemidji Minnesota
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Wood County Oncology Center Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Rocky Mountain Oncology Casper Wyoming
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Adena Regional Medical Center Chillicothe Ohio
United States Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio
United States Medical Oncology and Hematology Associates - West Des Moines Clive Iowa
United States North Coast Cancer Care - Clyde Clyde Ohio
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Luther Midlelfort Hospital Eau Claire Wisconsin
United States Midelfort Clinic - Luther Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Hematology Oncology Center Elyria Ohio
United States Green Bay Oncology, Limited - Escanaba Escanaba Michigan
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Broadway Fargo North Dakota
United States Fergus Falls Medical Group, PA Fergus Falls Minnesota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Front Range Cancer Specialists Fort Collins Colorado
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States Cancer Care Associates Fresno California
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Wayne Hospital Greenville Ohio
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Northern Montana Hospital Havre Montana
United States Geisinger Hazleton Cancer Center Hazleton Pennsylvania
United States St. Peter's Hospital Helena Montana
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Dickinson County Healthcare System Iron Mountain Michigan
United States Foote Memorial Hospital Jackson Michigan
United States Baptist Cancer Institute - Jacksonville Jacksonville Florida
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Regional Cancer Center Lansing Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States Southwest Medical Center Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States St. Mary Mercy Hospital Livonia Michigan
United States Drs. Carrol, Sheth, Raghavan Louisville Kentucky
United States Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Northwest Ohio Oncology Center Maumee Ohio
United States St. Luke's Hospital Maumee Ohio
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Fisher-Titus Medical Center Norwalk Ohio
United States Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin
United States Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Immanuel Medical Center Omaha Nebraska
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Knight Cancer Institute at Oregon Health and Science University Portland Oregon
United States Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland Oregon
United States Northwest Cancer Specialists at Rose Quarter Cancer Center Portland Oregon
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Rapid City Regional Hospital Rapid City South Dakota
United States Reid Hospital & Health Care Services Richmond Indiana
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Rutherford Hospital Rutherfordton North Carolina
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States North Coast Cancer Care, Incorporated Sandusky Ohio
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Mercy Medical Center Springfield Ohio
United States St. John's Regional Health Center Springfield Missouri
United States Geisinger Medical Group - Scenery Park State College Pennsylvania
United States Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin
United States Flower Hospital Cancer Center Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States CCOP - Toledo Community Hospital Toledo Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Anne Mercy Hospital Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Southwest Washington Medical Center Cancer Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Precision Radiotherapy at University Pointe West Chester Ohio
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Clinton Memorial Hospital Wilmington Ohio
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Galanis E, Jaeckle KA, Anderson S, et al.: NCCTG phase II trial of bevacizumab in combination with sorafenib in recurrent GBM. [Abstract] J Clin Oncol 28 (Suppl 15): A-2018, 2010.

Outcome

Type Measure Description Time frame Safety issue
Primary 6-month Progression-free Survival Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan. at 6 months
Secondary Time to Progression Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan. Time from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years
Secondary Overall Survival Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up. Time from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years
See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00006080 - Fenretinide in Treating Patients With Recurrent Malignant Glioma Phase 2
Recruiting NCT00887146 - Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma Phase 3
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
Terminated NCT00227032 - Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme Phase 1
Completed NCT00112502 - Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme Phase 2
Terminated NCT00243022 - Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme Phase 2
Active, not recruiting NCT00278278 - Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas Phase 3
Active, not recruiting NCT00087815 - Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain N/A
Completed NCT00416819 - Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma N/A
Completed NCT00052286 - Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer N/A
Completed NCT00006093 - EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Phase 1/Phase 2
Recruiting NCT00004129 - Phosphorus 32 in Treating Patients With Glioblastoma Multiforme Phase 1
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00003417 - Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme Phase 1/Phase 2
Completed NCT00003484 - Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00003464 - Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme Phase 2
Completed NCT00003020 - LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Phase 1
Completed NCT00008008 - Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma Phase 2