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=

Keywords:

Clinical Trial

Neoplasms

Eligibility Determination

Central Nervous System Neoplasms

Versions (2) ▾

12/9/13
6/2/15

Uploaded on:

June 2, 2015

DOI:

No DOI assigned. To request one pleaselog in.

License:

Creative Commons BY-NC 3.0 Legacy

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ACNS1123 Eligibility

Details

No Instruction available.

StudyEvent: SE.0000
1. No Instruction available.

Stratification

ACNS1123 Stratum

Stratum 1 - Nggct (Stratum 1 - NGGCT)

Stratum 2 - Germinoma (Stratum 2 - Germinoma)

Study Treatment

Treatment 1: A,b,a,b,a,b (Treatment 1 A B A B A B)

Treatment 2: A,a,a,a (Treatment 2 A A A A)

Treatment Begin Date (Projected date must be no later than 5 calendar days after the date of study enrollment. Enter as MM/DD/YYYY.)

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)

Yes (Yes)

No (No)

Elig - Block 3

Does patient have newly diagnosed localized primary CNS NGGCT?

Yes (Yes)

No (No)

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)

Yes (YES)

No (NO)

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.)

Yes (Yes)

No (No)

Elig - Block 4

Does patient have newly diagnosed localized primary CNS germinoma?

Yes (Yes)

No (No)

Yes (Yes)

No (No)

Elig - Block 5

Peripheral absolute neutrophil count (ANC) (number/uL)

Platelet count (number/uL): (Transfusion Independent)

1000/uL

Hemoglobin(g/dL) (May receive RBC transfusion)

g/dL

Elig - Block 5

Creatinine clearance (mL/min/1.73m²):

Radioisotope GFR(mL/min/1.73 m²)

mL/Min/1.73m2

Serum creatinine (mg/dL) (At study entry and based on age/gender per protocol section 3.2.5.2)

mg/dL

Elig - Block 7

Total bilirubin (mg/dl), ULN

mg/dL

Total bilirubin Value (mg/dl):

mg/dL

SGPT (ALT) or SGOT (AST) U/L, ULN:

SGPT (ALT) or SGOT (AST), U/L

Elig - Block 8

Does patient have seizure disorder?

Yes (Yes)

No (No)

Is patient's seizure disorder well controlled? (Adequate central nervous system function as defined in protocol section 3.2.5.4)

Yes (Yes)

No (No)

Is patient in status, coma or assisted ventilation at study entry?

Yes (Yes)

No (No)

Elig - Block 10

Date Informed Consent Signed

Have all institutional, FDA, and NCI requirements for human studies been met?

Yes (Yes)

No (No)

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ACNS1123 Eligibility

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