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Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003022
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Neuroblastoma Retinoblastoma Sarcoma Radiation: iodine I 131 monoclonal antibody 3F8 Phase 1

Detailed Description:


  • Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
  • Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
  • Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.

OUTLINE: This is a dose escalation study.

Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection.

Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
Study Start Date : April 1997
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignancy expressing GD2, including, but not limited to:

    • Medulloblastoma/primitive neuroectodermal tumor of the CNS
    • Malignant glioma
    • Neuroblastoma
    • Retinoblastoma
    • Ependymoma
    • Sarcoma
    • Melanoma
    • Small cell lung carcinoma
    • Other tumor types must have GD2 expression confirmed by immunohistochemical staining
  • Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
  • Prior measurable human anti-mouse monoclonal antibody titer allowed



  • 3 and over

Performance status:

  • Not specified

Life expectancy:

  • At least 2 months


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 50,000/mm^3


  • Bilirubin less than 3 mg/dL


  • Creatinine less than 2 mg/dL
  • Blood urea nitrogen less than 30 mg/dL


  • May have active malignancy outside the central nervous system
  • No obstructive hydrocephalus
  • No CNS grade 3 or 4 toxicity as a consequence of prior treatments
  • No life threatening infection


Biologic therapy:

  • Prior monoclonal antibody treatment allowed


  • Prior chemotherapy allowed
  • Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy

Endocrine therapy:

  • Not specified


  • Prior radiotherapy allowed
  • At least 6 weeks since prior cranial or spinal irradiation


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003022

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Kim Kramer, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
Layout table for additonal information Identifier: NCT00003022    
Other Study ID Numbers: 97-021
CDR0000065607 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
metastatic osteosarcoma
childhood infratentorial ependymoma
recurrent childhood rhabdomyosarcoma
childhood supratentorial ependymoma
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
recurrent neuroblastoma
intraocular retinoblastoma
extraocular retinoblastoma
recurrent retinoblastoma
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent osteosarcoma
recurrent adult brain tumor
iris melanoma
ciliary body and choroid melanoma, small size
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
recurrent intraocular melanoma
adult brain stem glioma
adult medulloblastoma
stage IV melanoma
recurrent melanoma
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
Additional relevant MeSH terms:
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Lung Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Nervous System Diseases
Retinal Neoplasms
Eye Neoplasms
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases