Trial record 2 of 5 for:    ANBL00B1

Collecting and Storing Tissue From Young Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00898755
First received: May 9, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

RATIONALE: Collecting and storing samples of tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer.


Condition Intervention
Cancer
Genetic: DNA analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: biologic sample preservation procedure
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Establishing Continuous Cell Lines and Xenografts From Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Myelocytic Leukemia Acute Myeloid Leukemia, Childhood Acute Non Lymphoblastic Leukemia Bone Cancer Brain Stem Glioma, Childhood Burkitt Lymphoma Cerebellar Astrocytoma, Childhood Cerebral Astrocytoma, Childhood Choriocarcinoma Chronic Myeloid Leukemia Craniopharyngioma Ependymoma Ewing's Family of Tumors Ewing's Sarcoma Extracranial Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor Glioma Hand-Schuller-Christian Disease Hepatoblastoma Hepatocellular Carcinoma, Childhood Hodgkin Lymphoma Hodgkin Lymphoma, Childhood Kidney Cancer Langerhans Cell Histiocytosis Leukemia, Myeloid Liver Cancer Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphomatoid Granulomatosis Lymphosarcoma Malignant Germ Cell Tumor Malignant Mesenchymal Tumor Medulloblastoma Medulloblastoma, Childhood Meningioma Myelodysplastic Syndromes Neuroblastoma Neuroepithelioma Osteosarcoma Ovarian Germ Cell Tumor Pineoblastoma, Childhood Plasmablastic Lymphoma Renal Cancer Retinoblastoma Rhabdoid Tumor Small Non-cleaved Cell Lymphoma Soft Tissue Sarcoma Supratentorial Primitive Neuroectodermal Tumor Supratentorial Primitive Neuroectodermal Tumors, Childhood Testicular Cancer Wilms' Tumor Yolk Sac Tumor
U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Establishment of transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Creation of a bank of cell lines and generation of sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Characterization of cell lines from childhood cancers with respect to DNA PCR molecular HLA profile as a "fingerprint" of original cell line identity [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Characterization of cell lines for mycoplasma contamination [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Characterization of cell lines for expression of molecular makers that confirm the tumor-type of the cell line and the immortal nature of the cells (telomerase) and the expression of molecular markers that may correlate with drug resistance [ Time Frame: length of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tumor tissue


Estimated Enrollment: 500
Study Start Date: March 2007
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute Lymphoblastic Leukemia (ALL)
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Acute Myelogenous Leukemia (AML)
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Lymphoma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Osteogenic sarcoma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Ewing's family tumors (ESFT)
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Rhabdomyosarcoma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
PNET (central)
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Glioma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Astrocytoma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Rhabdoid tumors
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Retinoblastoma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Wilm's tumor
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Neuroblastoma (Patients not eligible for ANBL00B1)
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Diagnosis Pending (for presumed relapsed patients)
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Germ Cell Tumors
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Hepatoblastoma
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis
Other Diagnoses
Sample of blood, bone marrow, or of the tumor is removed for evaluation
Genetic: DNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: biologic sample preservation procedure Other: flow cytometry Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • Establish and bank cell lines and/or xenografts from pediatric patients with cancer.
  • Establish continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer.
  • Establish transplantable xenografts in immunocompromised mice from tumor cells that are difficult to establish as continuous cell lines in vitro.
  • Create a bank of cell lines and generate sufficient vials of cryopreserved cells for distribution to investigators with approved COG biology protocols.
  • Characterize cell lines from childhood cancers with respect to DNA short tandem repeat molecular profile as a "fingerprint" of original cell line identity.
  • Characterize cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts.
  • Characterize cell lines for mycoplasma contamination.
  • Characterize cell lines for expression of molecular makers that confirm the tumor-type of the cell line and the immortal nature of the cells (telomerase) and the expression of molecular markers that may correlate with drug resistance.

OUTLINE: This is a multicenter study. Specimens are stratified according to disease (acute lymphoblastic leukemia vs acute myeloid leukemia vs lymphoma vs osteogenic sarcoma vs Ewing family of tumors vs rhabdomyosarcoma vs primitive neuroectodermal tumor vs glioma vs astrocytoma vs rhabdoid tumors vs hepatoblastoma vs retinoblastoma vs Wilms tumor vs germ cell tumors vs other diagnoses).

Leftover tissue from diagnostic procedures and/or surgery is cryopreserved and banked. Blood and/or bone marrow are also collected and banked.

Cell lines are established and characterized via reverse-transcriptase polymerase chain reaction and/or flow cytometry for biomarkers and by DNA fingerprinting.

Markers to be identified may include the following:

  • Neuroblastoma: tyrosine hydroxylase, protein gene product (PGP) 9.5, GD2, HLA class I, and HSAN 1.2 antigens
  • Ewing family of tumors: EWS-FLI1, EWS-ERG, and PGP 9.5
  • Retinoblastoma: interphotoreceptor retinoid-binding protein
  • Acute lymphoblastic leukemia: immunophenotype
  • Alveolar rhabdomyosarcoma: PAX3-FKHR, PAX7-FKHR, and MyoD1
  • All cell types: telomerase expression including hTR and hTERT Mutations of TP53 gene are detected by flow cytometry and/or immunocytochemistry.

No results of these tests are provided to the patient, the patient's physician, or the patient's medical records.

PROJECTED ACCRUAL: A total of 500 specimens per stratum will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient that has been enrolled on a COG therapeutic, biology, or tissue banking protocol that allows collection of tissue for research and submission to a COG-designated resource laboratory is eligible for this study.

Criteria

DISEASE CHARACTERISTICS:

  • All malignant tissues from childhood cancers allowed including the following:

    • Brain tumors (all types)

      • Tissue should be submitted to CNS Committee Resource labs to be forwarded for this study, unless instructed otherwise on the COG web site
    • Ewing family of tumors
    • Rhabdomyosarcomas
    • Other soft tissue sarcomas
    • Osteogenic sarcomas
    • Rhabdoid tumors
    • Neuroblastomas

      • Viable material for cell culture for neuroblastoma is collected via COG-ANBL00B1 and should not be submitted via this study unless the patient cannot be enrolled on COG-ANBL00B1* NOTE: *The same applies to any similar biology studies from other disease committees
    • Retinoblastomas
    • Anaplastic Wilms tumor
    • Germ cell tumors
    • Leukemias/lymphomas

      • Acute myeloid leukemia (AML)

        • Blood samples and bone marrow samples from patients at second relapse and beyond may be submitted for this study
        • Bone marrow samples at diagnosis or first relapse must be submitted to an AML resource lab and will be forwarded for this study at the discretion of the AML Committee
      • Acute lymphoblastic leukemia (ALL)

        • Blood samples may be submitted directly to this study
        • Bone marrow samples must be submitted to an ALL resource lab and will be forwarded for this study at the discretion of the ALL Committee
  • Enrolled on a COG therapeutic, biology, or tissue banking protocol that allows collection of tissue for research and submission to a COG-designated resource laboratory

    • Participation in this protocol is not permitted until after tissue requirements for any active COG disease-specific therapeutic, biology, or banking protocols have been satisfied
    • Material may only be submitted for this protocol if tissue is available in excess of that required for satisfying active disease-specific therapeutic and biological protocols
  • Patients with diagnosis pending are eligible

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898755

  Show 44 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: C. Patrick Reynolds, MD, PhD Children's Hospital Los Angeles
Study Chair: Barry J. Maurer, MD, PhD Children's Hospital Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898755     History of Changes
Other Study ID Numbers: ABTR04B1, COG-ABTR04B1, CDR0000478867
Study First Received: May 9, 2009
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
childhood acute lymphoblastic leukemia in remission
unspecified childhood solid tumor, protocol specific
childhood acute myeloid leukemia in remission
childhood central nervous system germ cell tumor
childhood choroid plexus tumor
childhood chronic myelogenous leukemia
childhood craniopharyngioma
childhood diffuse large cell lymphoma
childhood extragonadal germ cell tumor
childhood grade III lymphomatoid granulomatosis
childhood infratentorial ependymoma
childhood teratoma
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
childhood supratentorial ependymoma
childhood high-grade cerebral astrocytoma
childhood low-grade cerebral astrocytoma
metastatic childhood soft tissue sarcoma
newly diagnosed childhood ependymoma
nonmetastatic childhood soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent childhood brain stem glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood ependymoma
recurrent childhood grade III lymphomatoid granulomatosis

ClinicalTrials.gov processed this record on October 22, 2014