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Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

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Trial Information

Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme


PRIMARY OBJECTIVES:

I. Determine the therapeutic efficacy of dasatinib, in terms of 6-month progression-free
survival, in all patients (i.e., stage 1B [closed to accrual as of 4/14/2009] and stage 2
[closed to accrual as of 4/14/2009] combined) with recurrent/progressive glioblastoma
multiforme or gliosarcoma.

SECONDARY OBJECTIVES:

I. Determine the therapeutic efficacy of this drug, in terms of a hybrid endpoint of 6-month
progression-free survival or objective response (complete or partial) rate, in patients in
stage 1B (closed to accrual as of 4/14/2009).

II. Determine overall survival of patients treated with this regimen. III. Determine the
toxicity of this regimen in these patients. IV. Determine radiographic response rate in
patients treated with this regimen. V. Determine progression-free survival of patients
treated with this regimen. VI. Explore molecular correlates of clinical outcome in patients
treated with this regimen.

VII. Explore pharmacokinetic correlates of dosing, toxicity, and efficacy.

OUTLINE: This a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

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


Inclusion Criteria:



- Histologically confirmed glioblastoma multiforme or gliosarcoma

- Pre-therapy tumor tissue available

- Meets 1 of the following criteria:

- Patients accrued to stage 1 (closed to accrual as of 4/14/2009) or stage 1B
(opened to accrual as of 4/14/2009) must have tumors overexpressing at least 2
known dasatinib targets (i.e., SRC, KIT, PDGFR, or EPHA2)

- Patients accrued to stage 2 (closed as of 4/14/2009) do not require
overexpression of SRC, KIT, PDGFR, or EPHA2

- Prior treatment with radiotherapy and temozolomide required

- Radiographic evidence of tumor progression by MRI or CT scan

- Must be on stable or decreasing doses of corticosteroids for at least 5 days
before baseline MRI or CT scan

- Measurable disease is not required in patients who recently underwent resection
provided the following conditions are met as applicable:

- Progression of disease necessitated surgery

- Polifeprosan 20 with carmustine implants (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

- Karnofsky performance status 60-100%

- Absolute neutrophil count ≥ 1,000 cells/mm³

- Platelet count ≥ 75,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

- WBC ≥ 3,000 cells/mm³

- Absolute lymphocyte count ≥ 500 cells/mm³

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- Creatinine ≤ 3 times ULN OR creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior invasive malignancy except for nonmelanomatous skin cancer unless
disease-free for a minimum of 3 years

- No severe active comorbidity, defined as any of the following:

- Clinically significant cardiovascular disease, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization
within the past 6 months

- Transmural myocardial infarction or ventricular tachyarrhythmia within the
past 6 months

- Prolonged QTc > 480 msec (by Fridericia's correction)

- Ejection fraction less than institutional normal

- Major conduction abnormality (unless a cardiac pacemaker is present)

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization

- No known AIDS

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to dasatinib

- No condition that impairs the ability to swallow or retain tablets, such as the
following:

- Gastrointestinal tract disease resulting in an inability to take oral medication
or a requirement for IV alimentation

- Prior surgical procedures affecting absorption

- Active peptic ulcer disease

- No other concurrent anticancer agents or therapies

- Prior surgery for recurrent/progressive disease allowed

- Recovered from prior surgery

- More than 4 weeks since prior radiotherapy and recovered

- More than 2 weeks since prior temozolomide and recovered

- More than 2 weeks since prior and no concurrent enzyme-inducing antiepileptic drugs

- No prior therapy except radiotherapy and temozolomide

- No prior stereotactic radiosurgery or brachytherapy

- At least 7 days since prior and no concurrent potent inhibitors of CYP3A4

- At least 7 days since prior and no concurrent agents with proarrhythmic potential

- At least 7 days since prior and no concurrent antithrombotic and/or antiplatelet
agents (e.g., warfarin, heparin, low molecular weight heparin, acetylsalicylic acid,
clopidogrel, ticlopidine, or Aggrenox)

- No locally acting antacids (Maalox, Mylanta) within 2 hours before or after study
treatment

- No concurrent systemic antacids, including H2 receptor antagonist or proton pump
inhibitors

- No concurrent ibuprofen or NSAIDs

- No concurrent large quantities of grapefruit or its juice

- No concurrent potent inducers of CYP3A4

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Andrew Lassman

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Radiology Imaging Network

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00744

NCT ID:

NCT00423735

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioblastoma
  • Gliosarcoma

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Medical University of South Carolina Charleston, South Carolina  29425-0721
Hurley Medical Center Flint, Michigan  48503
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Akron General Medical Center Akron, Ohio  44302
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
York Hospital York, Pennsylvania  17315
University of Texas Medical Branch Galveston, Texas  77555-1329
LDS Hospital Salt Lake City, Utah  84143
Boston Medical Center Boston, Massachusetts  02118
Bay Medical Center Panama City, Florida  32401
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Beebe Medical Center Lewes, Delaware  19958
Mercy Hospital Coon Rapids, Minnesota  55433
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Singing River Hospital Pascagoula, Mississippi  39581
Union Hospital of Cecil County Elkton MD, Maryland  21921
Solano Radiation Oncology Center Vacaville, California  95687
Independence Regional Health Center Independence, Missouri  64050
Hennepin County Medical Center Minneapolis, Minnesota  
University of Florida Gainesville, Florida  32610-0277
University of Rochester Rochester, New York  14642
University of Arizona Health Sciences Center Tucson, Arizona  85724
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
University Of Vermont Burlington,, Vermont  05403
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah  84112
Metro-Minnesota CCOP St. Louis Park, Minnesota  
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Memorial Health University Medical Center Savannah, Georgia  31404
M D Anderson Cancer Center Houston, Texas  77030
University of Cincinnati Cincinnati, Ohio  45267-0502
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania  17033
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
John B Amos Cancer Center Columbus, Georgia  31904
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Green Bay Oncology - Escanaba Escanaba, Michigan  49431
Green Bay Oncology - Iron Mountain Iron Mountain, Michigan  49801
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Truman Medical Center Kansas City, Missouri  64108
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Cox Medical Center Springfield, Missouri  65807
Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene, New Hampshire  03431
Cooper Hospital University Medical Center Camden, New Jersey  08103
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly, New Jersey  08060
Sparta Cancer Treatment Center Sparta, New Jersey  07871
Virtua West Jersey Hospital Voorhees Voorhees, New Jersey  08043
Highland Hospital Rochester, New York  14620
Aultman Health Foundation Canton, Ohio  44710
Samaritan North Health Center Dayton, Ohio  45415
Salem Hospital Salem, Oregon  97309
Wheeling Hospital Wheeling, West Virginia  26003
Saint Vincent Hospital Green Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's Hospital Green Bay, Wisconsin  54303
Saint Mary's Hospital Green Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent Hospital Green Bay, Wisconsin  54301-3526
Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Northeast Radiation Oncology Center Dunmore, Pennsylvania  18512
Radiological Associates of Sacramento Sacramento, California  95816
Sandra L Maxwell Cancer Center Cedar City, Utah  84720
Intermountain Medical Center Murray, Utah  84157
Utah Valley Regional Medical Center Provo, Utah  84603
Dixie Medical Center Regional Cancer Center Saint George, Utah  84770
Intermountain Health Care Salt Lake City, Utah  84103
Utah Cancer Specialists-Salt Lake City Salt Lake City, Utah  84106
Upper Delaware Valley Cancer Center Milford, Pennsylvania  18337
Thompson Cancer Survival Center at Methodist Oak Ridge, Tennessee  37830
Adams Cancer Center Gettysburg, Pennsylvania  17325
Cherry Tree Cancer Center Hanover, Pennsylvania  17331
Saint Luke's South Hospital Overland Park, Kansas  66213
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Francis Hospital Greenville, South Carolina  29601
Gundersen Lutheran La Crosse, Wisconsin  54601
University Pointe West Chester, Ohio  45069
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
IU Health Methodist Hospital Indianapolis, Indiana  46202
Fletcher Allen Health Care-Medical Center Burlington, Vermont  05401
Auburn Radiation Oncology Center Auburn, California  95603
Marshall Radiation Oncology Center Cameron Park, California  95682
Mercy San Juan Medical Center Carmichael, California  95608
Roseville Radiation Oncology Center Roseville, California  95661
Mercy General Hospital Radiation Oncology Center Sacramento, California  95819
Norris Cotton Cancer Center-North Saint Johnsbury, Vermont  05819
Covenant Medical Center-Lakeside Lubbock, Texas  79410
Cape Radiation Oncology Cape Girardeau, Missouri  63703
Innovative Cancer Research Consortium Glendale, California  91206
Thompson Cancer Survival Center - West Knoxville, Tennessee  37392