Collecting and Storing Tissue From Young Patients With Cancer - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00898755

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
Official Title:	Establishing Continuous Cell Lines and Xenografts From Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies

Resource links provided by NLM:

Genetics Home Reference related topics: Langerhans cell histiocytosis neuroblastoma retinoblastoma

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Hodgkin Disease Leukemia Liver Cancer Lymphoma Myelodysplastic Syndromes Neuroblastoma Soft Tissue Sarcoma Wilms' Tumor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Establishment and banking of cell lines and/or xenografts from pediatric patients with cancer [ Designated as safety issue: No ]
Establishment of continuous cell lines, under carefully controlled conditions, from pediatric patients with cancer [ 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 [ 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 [ 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 [ Designated as safety issue: No ]
Characterization of cell lines for the ability for sustained growth in tissue culture and/or as mouse xenografts [ Designated as safety issue: No ]
Characterization of cell lines for mycoplasma contamination [ 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 [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	March 2007

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

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

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

Show 44 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	C. Patrick Reynolds, MD, PhD	Children's Hospital Los Angeles
Investigator:	Barry J. Maurer, MD, PhD	Children's Hospital Los Angeles

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00898755 History of Changes
Other Study ID Numbers:	CDR0000478867, COG-ABTR04B1
Study First Received:	May 9, 2009
Last Updated:	February 9, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Lymphoma, Non-Hodgkin
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on February 09, 2012