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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00445965
First received: March 7, 2007
Last updated: November 5, 2014
Last verified: November 2014

March 7, 2007
November 5, 2014
January 2006
January 2015   (final data collection date for primary outcome measure)
  • Six-month overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A "response" is defined as a patient being alive six months after their first treatment.
Six-month overall survival
Complete list of historical versions of study NCT00445965 on ClinicalTrials.gov Archive Site
cumulative toxicities [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).
Not Provided
Not Provided
Not Provided
 
Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Intraocular Melanoma
  • Lung Cancer
  • Melanoma (Skin)
  • Metastatic Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Retinoblastoma
  • Sarcoma
  • Small Intestine Cancer
  • Genetic: DNA analysis
  • Other: immunologic technique
  • Other: pharmacological study
  • Radiation: iodine I 131 monoclonal antibody 3F8
  • Radiation: 131I-3F8
    Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
Experimental: 131I-3F8
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.
Interventions:
  • Genetic: DNA analysis
  • Other: immunologic technique
  • Other: pharmacological study
  • Radiation: iodine I 131 monoclonal antibody 3F8
  • Radiation: 131I-3F8
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
77
January 2015
January 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed GD2-expressing malignancy, including the following:

    • Medulloblastoma or primitive neuroectodermal tumor of the CNS
    • High-grade astrocytoma
    • Malignant glioma
    • Neuroblastoma
    • Retinoblastoma
    • Ependymoma
    • Rhabdoid tumors
    • Sarcomas
    • Melanoma
    • Small cell lung carcinoma
    • Desmoplastic small round cell tumor
    • Other tumor types with GD2 expression confirmed by immunohistochemical staining and assessed by the Memorial Sloan-Kettering Department of Pathology using prior frozen tissue, bone marrow, or cerebrospinal fluid cytology
  • Must meet 1 of the following criteria:

    • Refractory to conventional therapies
    • Disease for which no conventional therapy exists
    • Recurrent brain tumors with a predilection for leptomeningeal dissemination (e.g., medulloblastoma, supratentorial primitive neuroectodermal tumor, rhabdoid tumor)
  • Patients with active malignancy outside the central nervous system are eligible

    • No obstructive or symptomatic communicating hydrocephalus

PATIENT CHARACTERISTICS:

  • Absolute neutrophil count > 1,000/mm³
  • Platelet count > 50,000/mm³
  • No uncontrolled life-threatening infection
  • No rapidly progressing or deteriorating neurologic examination
  • No severe major organ toxicity (i.e., renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity ≤ grade 2)
  • Stable neurological deficits (due to brain tumor) allowed
  • No hearing loss > 3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No cranial or spinal irradiation within the past 3 weeks
  • No prior craniospinal radiation > 45 Gy or focal brain radiation > 72 Gy
  • No systemic chemotherapy within the past 3 weeks (corticosteroids allowed)
  • Programmable shunt allowed
Both
Not Provided
No
Contact: Kim Kramer, MD 212-639-6410
Contact: Nai-Kong Cheung, MD, PhD 646-888-2313
United States
 
NCT00445965
05-122, MSKCC-05122
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Study Chair: Kim Kramer, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP