NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

Alliance N0577 - "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"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Brain/CNS Clinical Trial

CANCER TYPE: Glioma
RESEARCH BASE: Alliance
NCT NUMBER: NCT00887146
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
UPDATED ON 08/15/2018 (20:12:39)

Additional Consent Form: VIEW CONSENT FORM 2
UPDATED ON 08/15/2018 (20:12:39)

Additional Consent Form: VIEW CONSENT FORM 3
UPDATED ON 08/15/2018 (20:12:39)

BRIEF DESCRIPTION

Glioma, grade II or III, 1p and 19q co-deletion, IDH mutation, adjuvant, RT + TMZ vs RT + PCV  DCP-001 Eligible



NOTES


Treatment      (Supplied Drug:  None)

Arm A:

Cycle 1:  RT

For anaplastic glioma: Radiotherapy is performed as 33 fractions of 1.8 Gy for a total dose of 59.4 Gy. One fraction is given daily five days per week for about 6 to 7 weeks. Cycle 1 is about 6 to 7 weeks long total.

For low grade glioma, radiotherapy is performed as 28 fractions of 1.8 Gy for a total dose of 50.4 for over approximately 5 to 6 weeks.

Cycle 2:  Rest period 4 weeks +/- 2 weeks

Cycle 3-8:  PCV chemotherapy, cycles are about 6 to 7 weeks long each.

Day 1: CCNU 110 mg/m2 orally;
Days 8 and 29: vincristine 1.4 mg/m2 IV (capped at 2mg)
Days 8 to 21: procarbazine 60 mg/m2 orally;

Arm B:

Cycle 1:  RT

For anaplastic glioma: Radiotherapy is performed as 33 fractions of 1.8 Gy for a total dose of 59.4 Gy. One fraction is given daily five days per week for about 6 to 7 weeks. Cycle 1 is about 6 to 7 weeks long total.

For low grade glioma, radiotherapy is performed as 28 fractions of 1.8 Gy for a total dose of 50.4 for approximately 6 weeks.

AND

TMZ

For patients with anaplastic glioma, Temozolomide (TMZ) is given as 75 mg/m2 orally daily from the first day to the last day of administration of the 33 fractions of RT during Cycle 1; Cycle 1 is about 6 to 7 weeks long.

For patients with low grade glioma, Temozolomide (TMZ) is given as 75 mg/m2 orally daily from the first day to the last day of administration of the 28 fractions of RT during Cycle 1; Cycle 1 is about 5 to 6 weeks long.

Cycle 2:  Rest period 4 weeks +/- 3 days

Cycle 3-8:  TMZ

Adjuvant temozolomide (TMZ) is given as 150 mg/m2 days 1-5 only during cycle 3, then 150mg- 200 mg/m2 orally on days 1 to 5 only of each subsequent cycle. Cycles are about 4 weeks long each. TMZ will be administered for 6 cycles, which may be extended to 12 cycles at the discretion of the site investigator, provided the patient shows acceptable tolerance and no evidence of progression per protocol. Note: If patient does not complete planned cycles, they should proceed to observation phase until PD.



ELIGIBILITY

Pre-Registration

  • Central pathology review submission
    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 (see Sections 17.2 and 17.51). It should be initiated as soon after surgery as possible.
  • Tissue must have been determined to have local 1p/19q 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 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 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

  • Age ≥ 18 years of age.
  • 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 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.
  • The following laboratory values obtained ≤ 21 days prior to registration.
    • Absolute neutrophil count (ANC) ≥1500 /mm3
    • Platelet (PLTs) count ≥100,000 / mm3
    • Hemoglobin (Hgb) > 9.0 g/dL
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    • SGOT (AST) ≤ 3 x ULN Creatinine ≤ 1.5 x ULN
  • 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) (see Section 4.3).
  • ECOG performance status (PS) of 0, 1 or 2
  • 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 (see Sections 6.17, 17.3, and 17.52-17.53), 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 (see Sections 6.17 and 14.0). 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.
  • Fetal /Newborn Toxicity
    This study involves agents that have known genotoxic, mutagenic and teratogenic effects, and thus 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.
  • No 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 as long as other criteria stated in 3.2 and 3.3 are met.
  • No 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.
  • No 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 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.
  • No 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.
  • Not Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm.
  • No 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 if 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.
  • No History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • No Recent history of hepatitis infection or if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis.
  • Both men and women of all races and ethnic groups are eligible for this study.





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