Pre-Registration Inclusion Criteria:
Central Pathology Review Submission: This review is mandatory prior to registration to
confirm eligibility. Patients must be willing to submit tissue samples for mandatory
central pathology review submission and deletion status determination. It should be
initiated as soon after surgery as possible.
Registration Inclusion Criteria:
1. Age ≥ 18 years
2. Newly diagnosed and ≤ 3 months from surgical diagnosis
3. Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or
astrocytoma [WHO grade 2 or 3] or low grade glioma [WHO grade 2], as determined by
pre-registration central pathology review. 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.
4. Patients with codeleted low grade gliomas must also be considered "high risk" by
clinical criteria utilized in RTOG 9802 and must be either: age ≥ 40 and any surgical
therapy or age < 40 and subtotal resection or biopsy.
5. Tumor tissue must show co-deletion for the relevant portions of chromosomes 1p and 19q
by FISH analysis, as defined by the testing laboratory.
6. Surgery (partial or gross total resection or biopsy) must be performed ≥ 2 weeks prior
to registration. Patient must have recovered from the effects of surgery.
7. The following laboratory values obtained ≤ 21 days prior to registration.
1. Absolute neutrophil count (ANC) ≥ 1500/mm^3
2. Platelet (PLTs) count ≥ 100,000/mm^3
3. Hemoglobin (Hgb) > 9.0g/dL
4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
5. Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST) ≤ 3 x
ULN
6. Creatinine ≤ 1.5 x ULN
8. Negative serum or urine pregnancy test done ≤ 7 days prior to registration for women
of childbearing potential only.
9. Willing and able to complete neurocognitive testing without assistance and the Quality
of Life (QOL) questionnaires with or without assistance
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
11. Provide informed written consent.
12. Willing to return to enrolling institution for follow-up during the Active Monitoring
Phase (ie, active treatment and observation portion) of the study
13. Mandatory Tissue Samples for Correlative Research -Patient willing to provide tissue
samples for correlative research purposes
Registration Exclusion Criteria:
1. Fetal/Newborn Toxicity: Any of the following because this study involves an agent that
has known genotoxic, mutagenic and teratogenic effects: Pregnant women, nursing women,
men or women of childbearing potential who are unwilling to employ adequate
contraception during this study and for up to 6 months following the completion of
temozolomide treatments.
2. Received any prior surgery, radiation therapy or chemotherapy for any central nervous
system (CNS) neoplasm. Note: Patients who have had a prior low grade glioma with or
without surgery and who now have anaplastic glioma with no prior radiation or
chemotherapy are eligible for the study.
3. 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.
4. Concomitant serious immunocompromised status (other than that related to concomitant
steroids) that would compromise the safety of the patient on the study.
5. Patients known to be Human Immunodeficiency Virus (HIV) positive and currently
receiving retroviral therapy. Note: Patients known to be HIV positive, but without
clinical evidence of an immunocompromised state, are eligible for the study.
6. 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.
7. Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm.
8. 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 must not be receiving other specific
treatment (other than hormonal therapy) for their cancer.
9. History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use
of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
10. Recent history of hepatitis infection or treating physician determined that the
patient would be at significant risk of reactivation of hepatitis.
Eligibility CriteriaPhysical gender of individuals who may participate in the protocol.
Minimum and/or maximum age of participants.
Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.