Clinical Trials /

Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer

NCT00445965

Description:

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal metastases. PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.

Related Conditions:
  • Astrocytoma
  • Cancer
  • Central Nervous System Primitive Neuroectodermal Tumor
  • Ependymoma
  • Glioma
  • Medulloblastoma
  • Melanoma
  • Neuroblastoma
  • Retinoblastoma
  • Rhabdoid Tumor
  • Sarcoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Iodine I 131 <span class="go-doc-concept go-doc-intervention">Monoclonal Antibody</span> 3F8 in Treating Patients With <span class="go-doc-concept go-doc-disease">Central Nervous System Cancer</span> or Leptomeningeal <span class="go-doc-concept go-doc-disease">Cancer</span>

Title

  • Brief Title: Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
  • Official Title: Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms
  • Clinical Trial IDs

    NCT ID: NCT00445965

    ORG ID: 05-122

    NCI ID: MSKCC-05122

    Trial Conditions

    Brain and Central Nervous System Tumors

    Intraocular Melanoma

    Lung Cancer

    Melanoma (Skin)

    Metastatic Cancer

    Neuroblastoma

    Ovarian Cancer

    Retinoblastoma

    Sarcoma

    Small Intestine Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8,
    can find tumor cells and carry tumor-killing substances to them without harming normal
    cells. This may be an effective treatment for central nervous system cancer or
    leptomeningeal metastases.

    PURPOSE: This phase II trial is studying the side effects and how well iodine I 131
    monoclonal antibody 3F8 works in treating patients with central nervous system cancer or
    leptomeningeal cancer.

    Detailed Description

    OBJECTIVES:

    - Determine if intrathecal iodine I 131 monoclonal antibody 3F8 activity in patients with
    GD2-expressing central nervous system or leptomeningeal neoplasms is sufficiently
    promising (i.e., 6-month overall survival rate 25%) to warrant further study.

    - Determine the response rate in patients treated with this drug.

    - Determine the cumulative toxicities of this drug in these patients.

    - Describe the effects of human-antimouse antibody on cerebrospinal fluid and serum
    pharmacokinetics in patients treated with this drug.

    OUTLINE: This is an open-label study.

    Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 for dosimetry. Beginning
    approximately 1 week later, patients receive intrathecal iodine I 131 monoclonal antibody
    3F8 on day 1. Treatment intrathecal iodine I 131 monoclonal antibody 3F8 repeats weekly for
    up to 4 courses in the absence of disease progression or unacceptable toxicity.

    Blood and cerebrospinal fluid samples are collected prior to and after administration of
    each course of study drug. Samples are analyzed to assess the intrathecal and blood
    pharmacokinetics of iodine I 131 monoclonal antibody 3F8 and serum human antimouse
    antibodies. Samples are also analyzed in tumor genetic studies.

    After completion of study treatment, patients are followed periodically for 3 months.

    Trial Arms

    Name Type Description Interventions
    131I-3F8 Experimental This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease.

    Eligibility Criteria

    Inclusion Criteria:

    - Patients must have a histologically confirmed diagnosis of a malignancy known to
    expressGD2. Such tumors include medulloblastoma/primitive neuroectodermal tumor of
    the CNS, high grade astrocytomas, malignant glioma, neuroblastoma, retinoblastoma,
    ependymoma, rhabdoid tumors, sarcomas, melanoma or small cell lung carcinoma. For
    patients with other tumor types, GD2 expression must be confirmed by
    immunohistochemical staining and assessed by the Department of Pathology using prior
    frozen tissue, bone marrow or CSF cytology (send to Research Lab).

    - Patients must have CNS/ leptomeningeal disease including high risk medulloblastoma,
    or a CNS/leptomeningeal malignancy which is refractory to conventional therapies, or
    for which no conventional therapy exists, OR a recurrent brain tumors with a
    predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid
    tumor).

    - Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count
    > 50,000/ul.

    - Patients may have active malignancy outside the central nervous system.

    - Patients who have a programmable shunt will not be excluded.

    - Both pediatric and adult patients of any age are eligible.

    - Patients or a legal guardian will sign an informed consent form approved by the IRB
    and obtained by the Principal or a Co- Investigator before patient entry. Minors will
    provide assent.

    Exclusion Criteria:

    - Patients with obstructive or symptomatic communicating hydrocephalus.

    - Patients with an uncontrolled life-threatening infection.

    - Patients who are pregnant: Pregnant women are excluded for fear of danger to the
    fetus. Therefore negative pregnancy test is required for all women of child-bearing
    age, and appropriate contraception is required during the study period.

    - Patients who have received cranial or spinal irradiation less than 3 weeks prior to
    the start of this protocol.

    - Patients who have received systemic chemotherapy (corticosteroids not included) less
    than 3 weeks prior to the start of this protocol.

    - Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and
    gastrointestinal system toxicity should all be less than or equal to grade 2.
    Patients with stable neurological deficits (because of their brain tumor) are not
    excluded. Patients with <= 3 hearing loss are not excluded.

    - Patients must have no rapidly progressing or deteriorating neurologic examination.

    - Patients who have already received >45 Gy to the craniospinal radiation or >72 Gy
    focal brain radiation.

    Minimum Eligible Age: N/A

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Six-month overall survival

    response rate

    Secondary Outcome Measures

    cumulative toxicities

    Trial Keywords

    recurrent childhood medulloblastoma

    untreated childhood medulloblastoma

    adult supratentorial primitive neuroectodermal tumor (PNET)

    recurrent childhood supratentorial primitive neuroectodermal tumor

    untreated childhood supratentorial primitive neuroectodermal tumor

    adult anaplastic astrocytoma

    adult diffuse astrocytoma

    adult pilocytic astrocytoma

    adult subependymal giant cell astrocytoma

    recurrent childhood subependymal giant cell astrocytoma

    untreated childhood subependymal giant cell astrocytoma

    recurrent childhood cerebellar astrocytoma

    recurrent childhood cerebral astrocytoma

    untreated childhood cerebellar astrocytoma

    adult brain stem glioma

    adult mixed glioma

    childhood mixed glioma

    recurrent childhood brain stem glioma

    recurrent childhood visual pathway and hypothalamic glioma

    recurrent childhood visual pathway glioma

    untreated childhood brain stem glioma

    untreated childhood visual pathway and hypothalamic glioma

    untreated childhood visual pathway glioma

    regional neuroblastoma

    disseminated neuroblastoma

    recurrent neuroblastoma

    extraocular retinoblastoma

    recurrent retinoblastoma

    adult anaplastic ependymoma

    adult ependymoblastoma

    adult ependymoma

    adult myxopapillary ependymoma

    adult subependymoma

    childhood infratentorial ependymoma

    childhood supratentorial ependymoma

    recurrent childhood ependymoma

    childhood atypical teratoid/rhabdoid tumor

    recurrent melanoma

    stage IV melanoma

    adult medulloblastoma

    chondrosarcoma

    metastatic osteosarcoma

    recurrent osteosarcoma

    metastatic childhood soft tissue sarcoma

    ovarian sarcoma

    recurrent childhood soft tissue sarcoma

    stage III adult soft tissue sarcoma

    stage IV adult soft tissue sarcoma

    stage III uterine sarcoma

    stage IV uterine sarcoma

    previously treated childhood rhabdomyosarcoma

    recurrent childhood rhabdomyosarcoma

    adult anaplastic oligodendroglioma

    adult desmoplastic small round cell tumor

    adult oligodendroglioma

    adult giant cell glioblastoma

    adult gliosarcoma

    tumors metastatic to brain

    adult rhabdomyosarcoma

    childhood oligodendroglioma

    childhood desmoplastic small round cell tumor

    extensive stage small cell lung cancer

    intraocular retinoblastoma

    recurrent adult brain tumor

    recurrent adult soft tissue sarcoma

    recurrent uterine sarcoma

    small intestine leiomyosarcoma

    recurrent small intestine cancer

    recurrent small cell lung cancer

    extraocular extension melanoma

    recurrent intraocular melanoma

    metastatic intraocular melanoma

    iris melanoma

    ciliary body and choroid melanoma, medium/large size

    newly diagnosed childhood ependymoma

    adult glioblastoma

    metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

    recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

    recurrent childhood pineoblastoma

    untreated childhood pineoblastoma

    adult pineal gland astrocytoma

    stage IIIA melanoma

    stage IIIB melanoma

    stage IIIC melanoma

    recurrent childhood anaplastic astrocytoma

    untreated childhood anaplastic astrocytoma

    recurrent childhood anaplastic oligoastrocytoma

    recurrent childhood anaplastic oligodendroglioma

    untreated childhood anaplastic oligoastrocytoma

    untreated childhood anaplastic oligodendroglioma

    recurrent childhood giant cell glioblastoma

    recurrent childhood glioblastoma

    untreated childhood giant cell glioblastoma

    untreated childhood glioblastoma

    recurrent childhood gliosarcoma

    untreated childhood gliosarcoma

    recurrent childhood gliomatosis cerebri

    untreated childhood gliomatosis cerebri

    childhood high-grade cerebellar astrocytoma

    childhood high-grade cerebral astrocytoma