Description:

ACNS1123 Eligibility Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

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Versions (2) ▾
  1. 12/9/13
  2. 6/2/15
Uploaded on:

June 2, 2015

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License:
Creative Commons BY-NC 3.0 Legacy
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ACNS1123 Eligibility

Details

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Stratification
ACNS1123 Stratum
Study Treatment
TUMOR LOCATION Elig - Block 1
Is the patient enrolled on the ALTE07C1 study?
Is the patient greater than or equal to 3 years and less than or equal to 21 years at the time of enrollment?
Was definitive diagnostic surgery performed?
Was lumbar CSF cytology obtained?
Was it medically contraindicated? (If no,)
Was lumbar CSF cytology negative?
TUMOR LOCATION Elig - Block 2
Does patient have germ cell tumor(s) located in the suprasellar, pineal, bifocal (pineal + suprasellar) or ventricles? (Tumors present in the above mentioned locations and with unifocal parenchymal extension)
Elig - Block 3
Does patient have newly diagnosed localized primary CNS NGGCT?
Does patient have any of the following elements on biopsy/resection? (endodermal sinus tumor yolk sacor embryonal carcinoma or choriocarcinoma or malignant/immature teratoma or mixed GCT with malignant GCT elements)
Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
Elig - Block 4
Does patient have newly diagnosed localized primary CNS germinoma?
Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
Elig - Block 5
ul
1000/uL
g/dL
Elig - Block 5
mL/Min/1.73m2
mg/dL
Elig - Block 7
mg/dL
mg/dL
Elig - Block 8
Does patient have seizure disorder?
Is patient's seizure disorder well controlled? (Adequate central nervous system function as defined in protocol section 3.2.5.4)
Is patient in status, coma or assisted ventilation at study entry?
Elig - Block 9
Does patient have mature teratoma with normal tumor markers?
Does patient have tumors located outside the ventricles? (basal ganglia, thalamus)
Does patient have metastatic disease by either MRI evaluation or lumbar CSF cytology?
Prior to study enrollment, has patient been treated with therapy other than surgical intervention and corticosteroids?
Is patient post menarcheal?
Was a pregnancy test performed?
Is patient pregnant? (If yes above,)
Is patient nursing?
Has patient agreed to stop breastfeeding? (If yes above,)
Has patient agreed to use an effective contraceptive method for the duration of the study participation?
Elig - Block 10
Have all institutional, FDA, and NCI requirements for human studies been met?
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