Study of Kidney Tumors in Younger Patients

Status: Recruiting
Phase: N/A
DFCI Protocol ID: 06-159

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Conducting Institutions:

Dana-Farber Cancer Institute, Massachusetts General Hospital, Children's Hospital Boston

Overall PI:

Elizabeth Mullen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Mary Huang, MD, Massachusetts General Hospital

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria:

  -  Patients with the first occurrence of any tumor of the kidney identified on CT scan
     or MRI are eligible for this study; histologic diagnosis is not required prior to
     enrollment but is required for all patients once on study

  -  Eligible tumors include (but are not limited to):

       -  Nephroblastic tumors

    -  Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse,
       focal])

    -  Nephrogenic rests and nephroblastomatosis

    -  Cystic nephroma and cystic partially differentiated nephroblastoma

    -  Metanephric tumors (metanephric adenoma, metanephric adenofibroma,
       metanephric stromal tumor)

       -  Mesoblastic nephroma (cellular, classic, mixed)

       -  Clear cell sarcoma

       -  Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central
  nervous system [CNS])

       -  Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary
  renal cell carcinoma, renal tumors associated with Xp11.2 translocations,
  oncocytic renal neoplasms after neuroblastoma)

       -  Angiolipoma

       -  Ossifying renal tumor of infancy

  -  Patients with the first occurrence of the following tumors are also eligible:

       -  Extrarenal nephroblastoma or extrarenal neprogenic rests

       -  Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System

  -  Required specimens, reports, and copies of imaging studies must be available for
     submission or must become available during the required timeframe

  -  For ALL patients (with exception of bilateral, bilaterally predisposed or unilateral
     tumor in solitary kidney planning to enroll without biopsy), the following
     submissions are required:

       -  A complete set of recut hematoxylin and eosin (H & E) slides**

       -  Representative formalin-fixed paraffin-embedded tissue block or if a block is
  unavailable, 10 unstained slides from a representative block of tumor**

       -  Institutional pathology report, transmittal form and pathology checklist

       -  Copies of images and institutional reports of CT and/or MRI abdomen and pelvis

       -  Copies of images and institutional report of CT chest for all malignant tumors

       -  Institutional surgical report(s)

    -  Tissue must be from diagnosis, prior to any chemotherapy or radiation

  -  For patients with clinical features and required imaging findings consistent with the
     eligibility for the bilateral study, AREN0534 (or successor study), confirmed by
     central review, biopsy is not required; however, if biopsy is done, tissue must be
     submitted as for other renal tumors, and initial risk assignment will require
     pathology and surgical rapid central reviews; transmittal form and pathology
     checklist are also needed

  -  Patients with extrarenal Wilms tumor must have tumor tissue available for central
     review

  -  Patients with extra-CNS malignant rhabdoid tumor must have tumor tissue available for
     central review

  -  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

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