NCI ID NCI-2011-01915
NCT ID NCT00887146
CTEP ID N0577
Primary Purpose TREATMENT
Anatomic Sites Brain and Nervous System
Minimum Age 18 Years
Maximum Age 999 Years
Gender BOTH
Lead Org Alliance for Clinical Trials in Oncology
Principal Investigator Kurt A. Jaeckle
NCI Site View on ClinicalTrials.gov

Radiation Therapy or Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Anaplastic Glioma or Low Grade Glioma

This randomized phase III trial compares giving radiation therapy alone or temozolomide together with radiation therapy and to see which works best in treating patients with newly diagnosed 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy alone or temozolomide together with radiation therapy is better in treating anaplastic glioma or low grade glioma.

Eligibility

Inclusion Criterea

  • 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 and upload it in Rave * 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 upload it in Rave
  • REGISTRATION INCLUSION CRITERIA:
  • Age >= 18 years of age
  • Newly diagnosed and =< 3 months from surgical diagnosis. Patients not recently diagnosed (i.e. patients who had surgical procedure > 3 months earlier) with grade 2 or 3 gliomas are eligible if the patient has not received prior radiation or prior chemotherapy. Patients cannot have received prior treatment directed at this neoplasm with the exception of prior surgery
  • Histologic evidence of WHO Grade 2 or 3 oligodendroglioma, defined as a glioma with 1p/19q codeletion in combination with any IDH1 or IDH2 mutation. Codeletion and IDH status should be determined at the referring site’s local or reference laboratory * 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
  • Ability to read and comprehend English (or French for Canadian sites)

Exclusion Criterea

  • 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 3 years of registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; patients with low-risk prostate cancer who do not require treatment per European Society for Medical Oncology (ESMO) guidelines and under observation *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

Participating Clinics

Renown Regional Medical Center


1155 Mill Street
Reno, NV 89502
Map

702-384-0013
research@sncrf.org

Saint Mary's Regional Medical Center


235 West Sixth Street
Reno, NV 89503
Map

702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast


3980 South Eastern Avenue
Las Vegas, NV 89119
Map

702-384-0013
research@sncrf.org

Radiation Oncology Associates


6630 B South McCarran
Suite 18 Reno, NV 89509
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada


9280 West Sunset Road
Suite 100 Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central


624 South Tonopah Drive
Las Vegas, NV 89106
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Las Vegas


3006 South Maryland Parkway
Suite 100 Las Vegas, NV 89109
Map

702-384-0013
research@sncrf.org