Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Bevacizumab in Combination With Sorafenib in Recurrent Glioblastoma Multiforme
Verified date | April 2018 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
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.
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 |
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