Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT00335556
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed disease of 1 of the following histologic types:
* Focal anaplastic Wilms' tumor
* Diffuse anaplastic Wilms' tumor
* Clear cell sarcoma of the kidney
* Malignant rhabdoid tumor (renal or extrarenal)
* Renal cell carcinoma
* Clear cell
* Papillary
* Renal medullary
* Oncocytoid
* Sarcomatoid
* Chromophobe
* Translocation
* Collecting duct
* Carcinoma associated with neuroblastoma
* Renal cell carcinoma unclassified
* Specimens/materials must be submitted for central review by Day 7
* Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated
* Karnofsky performance status (PS) must be \>= 50 for patients \> 16 years if age and Lansky PS must be \>= 50 for patients =\< 16 years of age
* Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study
* Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ ALT\]) \< 2.5 times ULN for age
* Shortening fraction of \>= 27% by echocardiogram OR ejection fraction of \>= 50% by radionuclide angiogram
* Female patients of childbearing age must have a negative pregnancy test
* Female patients who are lactating must agree to stop breast-feeding
* Sexually active patients of childbearing potential must agree to use effective contraception
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
29 Years
Study:
NCT00335556
Study Brief:
Protocol Section:
NCT00335556