Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/8/2018
Start Date:September 2009
Contact:Kurt Jaeckle, MD
Phone:904-953-7102

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Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as temozolomide, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. It is not yet known whether giving
radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is
more effective in treating anaplastic glioma or low grade glioma.

This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q
anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with
1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A
dynamic allocation procedure will be used to allocate an equal number of patients to
different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of
the stratification factors among arms. The stratification factors that will be used are
cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. > 50), performance
score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma).

The primary goal is to determine whether patients who receive radiotherapy with concomitant
temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a
marginally better progression free survival (PFS) as compared with patients who receive
radiotherapy followed by PCV chemotherapy (RT --> PCV)(Arm A).

Secondary Goals:

1. Time to Progression - To determine whether patients who receive (RT + TMZ --> TMZ) have
a significantly longer time to progression (clinical or radiographic progression) as
compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy
(RT --> PCV).

2. Correlation between exploratory biomarkers and survival - To determine whether there is
a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT
promoter hypermethylation status.

3. Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive
comparisons of additional secondary outcome endpoints, including overall survival,
objective tumor response, prognostic factor analysis and quality of life.

4. Toxicity - To determine the toxicity of the treatment in each arm and perform
descriptive comparisons.

5. Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and
QOL effects in patients treated on this protocol and correlate these results with
outcome endpoints.

6. Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e.,
plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific
investigations.

After completion of study treatment, patients are followed every 12 weeks for 1 year, then
every 4 months for 2 years and then every 6 months until progressive disease or until the end
of study participation.

Pre-Registration Inclusion Criteria:

- United States (US) and Canadian sites:

* This review is mandatory prior to registration to confirm eligibility; patients must
be willing to submit tissue samples for mandatory central pathology review submission;
it should be initiated as soon after surgery as possible

- Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation
prior to submission for central path review

- Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility,
the 1p/19q analysis results will be accepted from the local site, as determined
by either a locally available or reference laboratory (for US, must be Clinical
Laboratory Improvement Act [CLIA] certified); acceptable methods for
determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by
genomic sequencing or methylomic analyses; US and Canadian sites must send a copy
of the official report to the pathology coordinator and quality assurance
specialist (QAS)

- Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic
analyses; this should be performed at the local site (US: performed in a CLIA
certified laboratory); the site must send a copy of the official report to the
pathology coordinator and QAS

Registration Inclusion Criteria:

- Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if
they have had a prior surgical procedure > 3 months earlier for low grade glioma, as
long as the patient has not received prior radiation or prior chemotherapy

- Histological evidence of World Health Organization (WHO) grade III anaplastic glioma
or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the
presence of an either IDH1 or IDH2, both as established by a local or referenced
laboratory qualified for the study

* Note: mixed gliomas are eligible, regardless of the degree of astrocytic or
oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q

- Patients with codeleted low grade gliomas must also be considered "high risk" by
exhibiting one or more of the following characteristics:

- Age >= 40 and any surgical therapy

- Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than
gross total resection)

- Documented growth following prior surgery (NOTE: patients with prior surgery
cannot have received prior radiation, chemotherapy or targeted therapy)

- Intractable seizures

- Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks
prior to registration; patient must have recovered adequately from the effects of
surgery

- Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to
registration

- Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration

- Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days
prior to registration

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3
x ULN obtained =< 21 days prior to registration

- Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration

- Negative serum or urine pregnancy test done =< 7 days prior to registration, for women
of childbearing potential only

- Willingness and ability to personally complete neurocognitive testing (without
assistance) and willingness to complete the QOL testing, (either personally or with
assistance)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2

- Written informed consent

- Willingness to return to enrolling institution for follow-up during the active
monitoring phase (that is, the active treatment and observation portion) of the
study); patients who have been formally transferred to another active and approved
site participating in this study would not need to return to the enrolling institution
for this purpose

- Willingness to allow the provision of tissue samples for correlative research, as long
as adequate tissues are available; patients will not be excluded from participation in
the study, if they are willing to allow provision of tissues for the correlative
research, but there are insufficient quantities of tissue for the correlative analyses
(e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to
allow the provision of blood samples for correlative research; patients are not
excluded from participation in the study, if they are willing to provide the mandatory
biospecimens for translational/correlative research, but for logistical reasons the
specimens(s) were not obtainable or if the volume collected was insufficient

Registration Exclusion Criteria:

- The following categories are ineligible:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception or contraceptive method during this study and 6 months following
the completion of chemotherapy treatments

- History of prior radiation therapy or chemotherapy for glioma; note: patients who have
a history of prior low grade glioma (with or without a distant history of prior
surgery for that glioma), but who have never received prior chemotherapy or radiation
therapy for the glioma are eligible for the study

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens

- Concomitant serious immunocompromised status (other than that related to concomitant
steroids) that would compromise the safety of the patient on the study

- Patients known to be human immunodeficiency virus (HIV) positive and currently
receiving retroviral therapy are not eligible; note: patients known to be HIV
positive, but without clinical evidence of an immunocompromised state, are eligible
for the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Receiving any other investigational agent that would be considered as a treatment for
the primary neoplasm

- Other active malignancy within 5 years of registration; exceptions: non-melanotic skin
cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior
malignancy, the patient is not eligible if they are receiving other specific treatment
(with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if
they have received prior total body irradiation which included the brain

- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

- Recent history of hepatitis infection or if the treating physician determined that the
patient would be at significant risk of reactivation of hepatitis
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Duluth, MN
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edina, MN
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Effingham, IL
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
Phone: 260-373-8888
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Fort Wayne, IN
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Fresno, California 93720
Principal Investigator: Uzair B. Chaudhary
Phone: 559-447-4050
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Fresno, CA
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Fresno, California 93701
Principal Investigator: Uzair B. Chaudhary
Phone: 559-256-9680
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Fresno, CA
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Fridley, MN
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1600 Southwest Archer Road
Gainesville, Florida 32610
Principal Investigator: David D. Tran
Phone: 888-823-5923
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Gainesville, FL
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Galesburg, Illinois 61401
Principal Investigator: Bryan A. Faller
Phone: 309-344-2831
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Galesburg, IL
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Grand Forks, North Dakota 58201
Principal Investigator: Grant R. Seeger
Phone: 701-780-6520
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Grand Forks, ND
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Grand Island, Nebraska 68803
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Grand Island, NE
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, MI
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Greenville, South Carolina 29601
Phone: 864-241-6251
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Greenville, SC
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Greenville, South Carolina 29605
Principal Investigator: David L. Grisell
Phone: 864-241-6251
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Greenville, SC
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Greenville, South Carolina 29605
Principal Investigator: David L. Grisell
Phone: 864-241-6251
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Greenville, SC
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Greenville, South Carolina 29615
Principal Investigator: David L. Grisell
Phone: 864-241-6251
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Greenville, SC
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Greer, South Carolina 29650
Principal Investigator: David L. Grisell
Phone: 864-241-6251
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Greer, SC
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24800 SE Stark St
Gresham, Oregon 97030
(503) 674-1122
Legacy Mount Hood Medical Center Legacy Mount Hood Medical Center, East County's full-service community hospital,...
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Gresham, OR
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Paul D. Brown
Phone: 855-776-0015
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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Jacksonville, Florida 32207
Principal Investigator: Robert Cavaliere
Phone: 904-202-7051
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Jacksonville, FL
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Kearney, Nebraska 68847
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Kearney, NE
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Kennewick, Washington 99336
Principal Investigator: Alison K. Conlin
Phone: 509-783-4637
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Kennewick, WA
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Kennewick, Washington 99336
Principal Investigator: George E. Laramore
Phone: 800-377-0856
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Kennewick, WA
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La Crosse, Wisconsin
Principal Investigator: Collin D. Driscoll
Phone: 608-775-2385
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La Crosse, WI
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La Grange, Illinois 60525
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La Grange, IL
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: David E. Piccioni
Phone: 858-822-5354
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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