Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:6/22/2018
Start Date:November 22, 2010

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Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, a COG Randomized Phase II Screening Trial

This randomized phase II trial studies how well giving temozolomide and irinotecan
hydrochloride together with or without bevacizumab works in treating young patients with
recurrent or refractory medulloblastoma or central nervous system (CNS) primitive
neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan
hydrochloride, work in different ways to stop the growth of tumor cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. 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. It is not yet known whether temozolomide and
irinotecan hydrochloride are more effective with or without bevacizumab in treating
medulloblastoma or CNS primitive neuroectodermal tumors.

PRIMARY OBJECTIVES:

l. To compare the overall survival (OS) of subjects receiving the combination of temozolomide
and irinotecan with that of subjects receiving temozolomide, irinotecan (irinotecan
hydrochloride), and bevacizumab for recurrent medulloblastoma (MB)/primitive neuroectodermal
tumor (PNET) of childhood.

SECONDARY OBJECTIVES:

I. To assess the response rate for each treatment arm amongst patients who are enrolled with
measurable disease.

II. To determine event-free survival (EFS) for each patient compared across regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive temozolomide orally (PO) and irinotecan hydrochloride IV over 90
minutes on days 1-5.

ARM II: Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and
bevacizumab IV over 30-90 minutes on days 1 and 15.

In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Inclusion Criteria:

- Medulloblastoma or PNET of childhood that has relapsed or become refractory to
standard chemotherapy; patients with pineoblastoma are eligible

- Patients must have had histologic verification of the malignancy at original diagnosis
or at the time of recurrence

- Patients must have clear residual disease, defined as tumor that is measurable in two
perpendicular diameters on magnetic resonance imaging (MRI) OR diffuse leptomeningeal
disease OR clear MRI evidence of disease that may not be measurable in two
perpendicular diameters

- All patients must have a brain MRI with and without gadolinium and a spine MRI with
gadolinium performed within 2 weeks prior to study enrollment

- Patients must have a Lansky or Karnofsky performance status score of >= 50%,
corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2
(use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of
age)

- Patients must have a life expectancy of >= 8 weeks

- Patients must have experienced at least one and at most two relapses prior to study
enrollment; patients with primary refractory disease are eligible

- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study

- Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry
onto this study (6 weeks if prior nitrosourea)

- Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy
with a biologic agent; at least 3 weeks for biologic agents with a long half
life, such as antibodies

- External beam radiation therapy (XRT): Must not have received craniospinal
radiotherapy within 24 weeks prior to study entry; the tumor designated as
"measurable" for protocol purposes must not have received radiation within 12
weeks prior to study entry); focal radiation to areas of symptomatic metastatic
disease must not be given within 14 days of study entry

- Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed
prior to study entry

- Study specific limitations on prior therapy:

- Patients must not have previously received bevacizumab, irinotecan,
temozolomide or other anti-vascular endothelial growth factor (VEGF)
inhibitor

- Patients must not be taking enzyme-inducing antiepileptic medicines within 1
week of study entry

- Patients must have recovered from any surgical procedure before enrolling on this
study:

- Patients with a major surgical procedure within 28 days prior to enrollment
should be excluded

- Patients with an intermediate surgical procedure within 14 days prior to
enrollment should be excluded

- For minor surgical procedures (including Broviac line or infusaport placement),
patients should not receive the first planned dose of bevacizumab until the wound
is healed and at least 7 days have elapsed

- There should be no anticipation of need for major surgical procedures during the
course of the study

- Examples of major, intermediate, or minor surgical procedures:

- Major procedures: Major craniotomy for tumor resection; organ
resection; bowel wall anastomosis; arteriovenous grafts; exploratory
laparotomy; thoracotomy

- Intermediate procedures: Ventriculoperitoneal (VP)-shunt placement;
stereotactic brain biopsy

- Minor procedures: Incision and drainage of superficial skin abscesses;
punch biopsy of skin lesions; superficial skin wound suturing; bone
marrow aspirate and/or biopsy; fine needle aspirations; Broviac line or
infusaport placement; paracentesis or thoracocentesis

- Please note: Lumbar punctures or placement of peripherally inserted central
catheter (PICC) lines are not considered minor procedures and may occur at any
time prior to or during therapy

- Hypertension must be well controlled (=< 95th percentile for age and height if patient
is =< 17 years) on stable doses of medication

- Concomitant medications restrictions:

- Growth factor(s): Must not have received within 7 days of entry onto this study

- Steroids: Patients who are receiving corticosteroids must be on a stable or
decreasing dose for at least 7 days

- Study Specific: Patients must not be currently taking nonsteroidal
anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy >
81 mg/day

- Peripheral absolute neutrophil count (ANC) >= 1000/uL (must not have received
filgrastim [G-CSF] within the prior 7 days)

- Platelet count >= 100,000/uL (transfusion independent)

- Hemoglobin >= 8.0 gm/dL (may receive packed red blood cell [PRBC] transfusions)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR
a serum creatinine based on age/gender as follows:

- =< 0.4 mg/dL (for patients aged 1 month to < 6 months)

- =< 0.5 mg/dL (for patients aged 6 months to < 1 year)

- =< 0.6 mg/dL (for patients aged 1 to < 2 years)

- =< 0.8 mg/dL (for patients aged 2 to < 6 years)

- =< 1 mg/dL (for patients aged 6 to < 10 years)

- =< 1.2 mg/dL (for patients aged 10 to < 13 years)

- =< 1.4 mg/dL (for female patients aged >= 13 years)

- =< 1.5 mg/dL (for male patients aged 13 to < 16 years)

- =< 1.7 mg/dL (for male patients aged >= 16 years)

- Urine protein should be screened by dipstick analysis; if protein >= 2+ on dipstick,
then urine protein creatinine (UPC) ratio should be calculated; if UPC ratio > 0.5,
24-hour urine protein should be obtained and the level should be < 1000 mg/24 hours
for patient enrollment

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x
upper limit of normal (ULN) for age

- Central nervous system function defined as

- Patients with a seizure disorder may be enrolled if well-controlled and on
non-enzyme inducing anticonvulsants

- Adequate coagulation defined as

- International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x upper limit
of normal

Exclusion Criteria:

- Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible
for this study

- Patients must not have a history of abdominal fistula, gastrointestinal perforation or
intra-abdominal abscess within 6 months prior to study entry

- Patients must not have a known bleeding diathesis or coagulopathy

- Patients must not have had significant vascular disease (eg, aortic aneurysm requiring
surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to
study entry

- Patients must not have a known thrombophilic condition (i.e. protein S, protein C or
antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation,
homocysteinemia or antiphospholipid antibody syndrome); testing is not required in
patients without thrombophilic history

- Patients must not have evidence of new CNS hemorrhage on baseline MRI obtained within
14 days prior to study enrollment

- Patients with a history of stroke, myocardial infarction, transient ischemic attack
(TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater
congestive heart failure within the past 6 months are not eligible

- Patients must not have serious and inadequately controlled cardiac arrhythmia

- Female patients who are pregnant are not eligible for this study

- Female patients who are breastfeeding are not eligible for this study unless they
agree not to breastfeed

- Female patients of childbearing potential must have a negative pregnancy test

- Sexually active patients of childbearing potential must agree to use an effective
method of contraception during the study and for at least 6 months after the
completion of bevacizumab therapy

- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human antibodies
We found this trial at
138
sites
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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9981 S Healthpark Dr # 465
Fort Myers, Florida 33908
239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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4015 22nd Place
Lubbock, Texas 79410
806-725-0000
Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
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9300 Valley Children's Pl
Madera, California 93720
(559) 353-3000
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Albany, New York 12208
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28204
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
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Chicago, Illinois 60614
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbia, Missouri 65201
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Dayton, Ohio 45404
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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East Lansing, Michigan 48824
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El Paso, Texas 79905
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801 Broadway North
Fargo, North Dakota 58122
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1600 Southwest Archer Road
Gainesville, Florida 32610
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
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Hershey, Pennsylvania 17033
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Honolulu, Hawaii 96813
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Hunter Regional Mail Centre, New South Wales
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Jacksonville, Florida 32207
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Las Vegas, Nevada 89144
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Las Vegas, Nevada 89109
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Louisville, Kentucky 40202
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Marshfield, Wisconsin 54449
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Miami, FL
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Minneapolis, Minnesota 55455
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Morristown, New Jersey 07962
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Morristown, NJ
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Nashville, Tennessee 37232
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New Brunswick, NJ
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