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Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

This study has been completed.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
Official Title  Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
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 cancer.

Detailed Description

OBJECTIVES:

  • 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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Brain and Central Nervous System Tumors
Intraocular Melanoma
Lung Cancer
Melanoma (Skin)
Neuroblastoma
Retinoblastoma
Sarcoma
Intervention  Drug: iodine I 131 monoclonal antibody 3F8
MEDLINE PMIDs 18048828
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  April 1997
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 3 and over

Performance status:

  • Not specified

Life expectancy:

  • At least 2 months

Hematopoietic:

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

Hepatic:

  • Bilirubin less than 3 mg/dL

Renal:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior monoclonal antibody treatment allowed

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified
Gender Both
Ages 3 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00003022
Organization ID CDR0000065607
Secondary IDs †† MSKCC-97021, NCI-G97-1267
Study Sponsor  Memorial Sloan-Kettering Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Kim Kramer, MD     Memorial Sloan-Kettering Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2005
First Received Date  November 1, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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