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

November 1, 1999
January 27, 2003
July 3, 2013
April 1997
January 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003022 on Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms

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.


  • 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.

Phase 1
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Intraocular Melanoma
  • Lung Cancer
  • Melanoma (Skin)
  • Neuroblastoma
  • Retinoblastoma
  • Sarcoma
Radiation: iodine I 131 monoclonal antibody 3F8
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Kramer K, Humm JL, Souweidane MM, Zanzonico PB, Dunkel IJ, Gerald WL, Khakoo Y, Yeh SD, Yeung HW, Finn RD, Wolden SL, Larson SM, Cheung NK. Phase I study of targeted radioimmunotherapy for leptomeningeal cancers using intra-Ommaya 131-I-3F8. J Clin Oncol. 2007 Dec 1;25(34):5465-70.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2005
January 2005   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
3 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000065607 ( Registry Identifier: PDQ (Physician Data Query) )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Kim Kramer, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
July 2013

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