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Baptist MD Anderson
1301 Palm Avenue
Jacksonville, FL 32207
Poonam K. Neki, MBBS,DA, CCRP
Baptist MD Anderson Clinical Trials
Clinical Trial ID: NCT00887146
N0577 (CODEL): 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
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).
To determine whether patients who receive radiotherapy with concomitant temozolomide 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 adjuvant PCV chemotherapy (RT > PCV) (ARM A).
Experimental: Radiation Therapy + Procarbazine + Lomustine + Vincristine Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Experimental: Radiation Therapy + Temozolomide Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.
Baptist MD Anderson Cancer Center
Inclusion Criteria: - Newly diagnosed and =< 3 months from surgical diagnosis - 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 - Patients with codeleted low grade gliomas must also be considered "high risk" - Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration - Absolute neutrophil count (ANC) >= 1,500/mm^3 - Platelet (PLTs) count >= 100,000/mm^3 - Hemoglobin (Hgb) > 9.0 g/dL - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN - Creatinine =< 1.5 x ULN - Negative serum or urine pregnancy test - Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing - 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) - 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 Exclusion Criteria: - 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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