Clinical Trials /

Study of Kidney Tumors in Younger Patients

NCT00898365

Description:

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.

Related Conditions:
  • Kidney Neoplasm
  • Rhabdoid Tumor
  • Wilms Tumor
Recruiting Status:

Suspended

Trial Eligibility

Document

Title

  • Brief Title: Study of Kidney Tumors in Younger Patients
  • Official Title: Renal Tumors Classification, Biology, and Banking Study

Clinical Trial IDs

  • ORG STUDY ID: AREN03B2
  • SECONDARY ID: NCI-2009-00416
  • SECONDARY ID: COG-AREN03B2
  • SECONDARY ID: CDR0000459797
  • SECONDARY ID: AREN03B2
  • SECONDARY ID: AREN03B2
  • SECONDARY ID: U10CA180886
  • SECONDARY ID: U10CA098543
  • SECONDARY ID: UG1CA189958
  • NCT ID: NCT00898365

Conditions

  • Adult Cystic Nephroma
  • Anaplastic Kidney Wilms Tumor
  • Angiolipoma
  • Cellular Congenital Mesoblastic Nephroma
  • Classic Congenital Mesoblastic Nephroma
  • Clear Cell Sarcoma of the Kidney
  • Congenital Mesoblastic Nephroma
  • Cystic Partially Differentiated Kidney Nephroblastoma
  • Diffuse Hyperplastic Perilobar Nephroblastomatosis
  • Extrarenal Rhabdoid Tumor
  • Kidney Medullary Carcinoma
  • Kidney Neoplasm
  • Kidney Oncocytoma
  • Kidney Wilms Tumor
  • Metanephric Adenofibroma
  • Metanephric Adenoma
  • Metanephric Stromal Tumor
  • Metanephric Tumor
  • Mixed Congenital Mesoblastic Nephroma
  • Ossifying Renal Tumor of Infancy
  • Papillary Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions
  • Rhabdoid Tumor of the Kidney
  • Wilms Tumor

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Classify patients with renal tumors by histological categorization, surgico-pathological
      stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for
      chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. (Loss of
      heterozygosity [LOH] testing discontinued as of April 2014) II. Maintain a biological samples
      bank to make specimens available to scientists to evaluate additional potential biological
      prognostic variables and for the conduct of other research by scientists.

      SECONDARY OBJECTIVES:

      I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic
      study.

      II. Describe whether the pulmonary tumor burden correlates with outcome in stage IV patients.

      III. Describe the sensitivity and specificity of abdominal computed tomography (CT) by
      comparison with surgical and pathologic findings for identification of local tumor spread
      beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal
      hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver.

      IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and magnetic
      resonance imaging (MRI) for the identification and differentiation of nephrogenic rests and
      Wilms' tumor in children with multiple renal lesions.

      V. Correlate the method of conception (natural vs assisted reproductive technology) with the
      development of Wilms' tumor.

      VI. To evaluate the frequency of integrase interactor 1 (INI1) mutations in renal and
      extrarenal malignant rhabdoid tumor of the kidney and to determine the incidence of germline
      and inherited versus somatic mutations to facilitate clinical correlations on the companion
      study AREN0321. (INI1 testing discontinued as of April 2014)

      OUTLINE:

      Tumor tissue, blood, and urine samples are collected for research studies, including
      immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses
      (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by
      polymerase chain reaction using standard methodology. Leftover specimens are archived for
      future studies. (LOH and INI1 testing discontinued as of April 2014)

      Patients are followed up periodically for 5 years.
    

Trial Arms

NameTypeDescriptionInterventions
Ancillary-correlative (renal tumor classification, biology)Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. (LOH and INI1 testing discontinued as of April 2014)

    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
          
    Maximum Eligible Age:29 Years
    Minimum Eligible Age:N/A
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Disease-free survival
    Time Frame:Up to 5 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Loss of heterozygosity (LOH testing discontinued as of April 2014)
    Time Frame:Up to 5 years
    Safety Issue:
    Description:

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Suspended
    Lead Sponsor:Children's Oncology Group

    Last Updated