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AzTrials

Adult Giant Cell GlioblastomaPhase 2NCT00423735

Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

A Phase 2 study testing Dasatinib and Pharmacological Study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 188 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dasatinib and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
188 sitesin 3 countries
Study dates
24 Jan 2007to 4 Sep 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis
  • The patient must consent to submission of tissue for central pathology review
  • Patients who have already undergone central pathology review through their enrollment on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to having their material re-reviewed by the central pathologist for this study
  • All patients must consent to molecular analysis of pre-dasatinib tumor tissue
  • Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5, 2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC proto-oncogene, non-receptor tyrosine kinase [SRC], v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog [KIT], platelet-derived growth factor receptor [PDGFR], or ephrin type-A receptor 2 [EPHA2])
  • Patients accrued to stage II (cohort closed; not currently applicable) do not require overexpression of SRC, KIT, PDGFR, or EPHA2
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  • History and physical examination, including height and weight, within 10 days prior to registration on study
  • Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days prior to registration on study
  • Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot undergo MRI scanning
  • Karnofsky performance status >= 60
  • Absolute neutrophil count (ANC) >= 1,000 cells/mm^3
  • Platelets >= 75,000 cells/mm^3
  • Hemoglobin (Hgb) >= 8.0 g/dl; (note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
  • Leukocytes >= 3,000 cells/mm^3
  • Absolute lymphocyte count (ALC) >= 500 cells/mm^3
  • Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 institutional upper limit of normal
  • Creatinine =< 3 X institutional upper limit of normal or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • All patients must have undergone prior treatment with radiotherapy and temozolomide; no other prior treatments are allowed
  • There must be unequivocal radiographic evidence for tumor progression by MRI or CT scan, and the same type of scan (i.e., MRI or CT) must be used throughout the period of protocol treatment for tumor measurement; patients must be on a stable or decreasing dose of corticosteroids for at least 5 days before the baseline MRI/CT is performed
  • Patients having undergone recent surgery for recurrent/progressive disease are eligible as long as they have recovered from the effects of surgery; patients who recently underwent resection without measurable disease post-operatively are also eligible
  • Measurable disease is not required for eligibility in patients who recently underwent resection as long as the following conditions are met as applicable:
  • Progression of disease led to the surgery
  • Gliadel wafers were not placed during the most recent surgery
  • Neither convection enhanced delivery nor catheters for infusion of chemotherapy were used during the most recent surgery
  • Radioactive seeds were not placed during the most recent surgery
  • The histology of the most recent surgery documented recurrent/persistent/progressive malignant glioma
  • Women of childbearing potential must have a negative beta human chorionic gonadotropin (B HCG) pregnancy test =< 3 days prior to registration
  • Patient must sign study-specific informed consent prior to study entry

Who cannot join

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Radiotherapy within 4 weeks or temozolomide within 14 days prior to registration or failure to recover from adverse events of either radiotherapy or temozolomide
  • Patients may not be receiving any other investigational agents
  • Severe, active comorbidity, defined as follows:
  • Any clinically significant cardiovascular disease including the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
Show all 22Show fewer
  • Transmural myocardial infarction or ventricular tachyarrhythmia within the past 6 months
  • Prolonged corrected QT interval (QTc) > 480 msec (Fridericia correction)
  • Ejection fraction less than institutional normal
  • Major conduction abnormality (unless a cardiac pacemaker is present)
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; breastfeeding should be discontinued if the mother is treated with dasatinib
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib
  • Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
  • Patients must not be taking hepatic enzyme inducing antiepileptic drugs (EIAEDs); if patients were previously on EIAEDs that have been discontinued, patients must have been off EIAEDs for >= 2 weeks prior to initiation of dasatinib
  • Patients who require antacids should use short-acting, locally active agents (e.g., Maalox, Mylanta etc.); however, these agents should not be taken within either 2 hours before or 2 hours after the dasatinib dose
  • Use of antithrombotic and/or antiplatelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, clopidogrel, ticlopidine, Aggrenox)
  • Use of ibuprofen or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded
  • Prior treatment with stereotactic radiosurgery (including Gamma-Knife, Cyberknife, or other variants) or brachytherapy

Trial locations and contacts

188 sites in 3 countries.

188 sites in 3 countries

United States184 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Cape Radiation Oncology

    Cape Girardeau, Missouri, 63703

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network-Southside Cancer Center

    Jacksonville, Florida, 32207

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network-Florida Cancer Center Beaches

    Jacksonville Beach, Florida, 32250

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cheshire Medical Center-Dartmouth-Hitchcock Keene

    Keene, New Hampshire, 03431

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Thompson Cancer Survival Center - West

    Knoxville, Tennessee, 37932

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Upper Delaware Valley Cancer Center

    Milford, Pennsylvania, 18337

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Thompson Cancer Survival Center at Methodist

    Oak Ridge, Tennessee, 37830

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • 21st Century Oncology-Orange Park

    Orange Park, Florida, 32073

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • 21st Century Oncology-Palatka

    Palatka, Florida, 32177

  • Bay Medical Center

    Panama City, Florida, 32401

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Reid Health

    Richmond, Indiana, 47374

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital Radiation Oncology Center

    Sacramento, California, 95819

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Integrated Community Oncology Network-Flager Cancer Center

    Saint Augustine, Florida, 32086

  • Norris Cotton Cancer Center-North

    Saint Johnsbury, Vermont, 05819

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • UH Seidman Cancer Center at Salem Regional Medical Center

    Salem, Ohio, 44460

  • Salem Hospital

    Salem, Oregon, 97301

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Shawnee Mission Medical Center-KCCC

    Shawnee Mission, Kansas, 66204

  • Sparta Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Saint John's Hospital

    Springfield, Illinois, 62702

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • The University of Arizona Medical Center-University Campus

    Tucson, Arizona, 85724

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • Virtua Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • University Pointe

    West Chester, Ohio, 45069

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Wheeling Hospital/Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Canada3 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

Other trials in Canada

Saudi Arabia1 site

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

Other trials in Saudi Arabia

About this study

Official title: Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme

This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the therapeutic efficacy of dasatinib in all patients (i.e., stages 1B and 2 combined) with recurrent/progressive glioblastoma (GBM) as measured by 6-month progression-free survival.

SECONDARY OBJECTIVES:

  1. To determine the therapeutic efficacy of dasatinib for stage 1B patients with recurrent/progressive GBM as measured by a hybrid endpoint of 6-month progression-free survival OR objective response of (complete response [CR] or partial response [PR]) rate.

II. To determine patient overall survival. III. To determine the toxicity of dasatinib in the treatment of patients with GBM.

IV. To determine radiographic response rate to treatment. V. To determine patient progression-free survival. VI. To explore molecular correlates of clinical outcome. VII. To explore pharmacokinetic correlates of dosing, toxicity, and efficacy.

OUTLINE:

Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.

After the completion of study treatment, patients are followed up periodically.

Medical subject headings
Glioblastoma, Gliosarcoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00423735
Study groupRoleWhat they receive
Treatment (dasatinib)ExperimentalPatients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
Receives: Drug: Dasatinib; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Achieving 6-month Progression-free Survival (6mPFS)

    This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.

    Measured: Registration to 6 months

Secondary outcomes (7)

  1. Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)

    Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint. Complete Response: Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial Response: ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved.

    Measured: Registration to 6 months

  2. Overall Survival

    Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. The study is not designed for a comparison of the treatment arms to each other.

    Measured: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)

  3. Treatment Response Rates at Six Months

    Best response is assessed using standard criteria for patients with malignant gliomas (Macdonald 1990) as reported by the site. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive CT or MRI scans at least 1 month apart; off corticosteroids; neurologically stable/improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive CT or MRI scans at least 1 month apart; corticosteroids stable/reduced; neurologically stable/improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; neurologically worse; steroids stable/increased. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression, up to six months. The study is not designed for a comparison of the treatment arms to each other.

    Measured: From registration to 6 months

  4. Progression-free Survival

    Progression-free survival time is measured from randomization to the date of first progression or death, else the last follow-up date on which the patient was reported alive, and is estimated by the Kaplan-Meier method. Progression is defined as ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased. The study is not designed for a comparison of the treatment arms to each other.

    Measured: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)

  5. Rate of Adverse Events

    The rate of patients' worst overall grade of adverse event is reported. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The study is not designed for a comparison of the treatment arms to each other.

    Measured: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)

  6. Correlation of Molecular Markers and Tumor Response

    The following markers were examined: p-SRC, PDGFR, EPHA2, c-KIT. Patients were categorized based on the number of positive molecular markers they had: 2 vs. 3 and 4. Correlation of marker category and best tumor response was tested using Fisher's exact test. The best tumor response is defined as the best radiographic response for patients evaluable for radiographic response prior to progression up to six months. Patients are combined from the two treatment arms.

    Measured: From registration to 6 months

  7. Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy

    Sufficient pharmacokinetic data was not obtained.

    Measured: Analysis occurs after all patients have been on study for at least 6 months. (Patients are followed from registration to death or study termination whichever occurs first.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study start24 Jan 2007
  3. Primary completion9 Mar 2011
  4. Study completion4 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423735
Sponsor's protocol ID
NCI-2009-00744
Other IDs
NCI-2009-00744, CDR0000526070, RTOG 0627, RTOG-0627, U10CA180868, U10CA021661
Status last verified
Jul 2019
First submitted
16 Jan 2007
Last updated
24 Jul 2019
Data monitoring committee
No

Publications

  • Lassman AB, Pugh SL, Gilbert MR, Aldape KD, Geinoz S, Beumer JH, Christner SM, Komaki R, DeAngelis LM, Gaur R, Youssef E, Wagner H, Won M, Mehta MP. Phase 2 trial of dasatinib in target-selected patients with recurrent glioblastoma (RTOG 0627). Neuro Oncol. 2015 Jul;17(7):992-8. doi: 10.1093/neuonc/nov011. Epub 2015 Mar 10.

    PubMed 25758746

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib and Pharmacological Study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 188 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Achieving 6-month Progression-free Survival (6mPFS) (time frame: Registration to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00423735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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