Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Intraocular Melanoma
Lung Cancer
Melanoma (Skin)
Neuroblastoma
Retinoblastoma
Sarcoma
Drug: iodine I 131 monoclonal antibody 3F8
Phase I

Genetics Home Reference related topics:   Soft Tissue Sarcoma   retinoblastoma  

MedlinePlus related topics:   Cancer   Lung Cancer   Melanoma   Neuroblastoma   Soft Tissue Sarcoma  

ChemIDplus related topics:   Iodine   Sodium iodide I 131   Cadexomer iodine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 1997

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.

  Eligibility
Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003022

Locations
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)

Investigators
Study Chair:     Kim Kramer, MD     Memorial Sloan-Kettering Cancer Center    
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair:     Kim Kramer, MD     Memorial Sloan-Kettering Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000065607, MSKCC-97021, NCI-G97-1267
First Received:   November 1, 1999
Last Updated:   June 21, 2008
ClinicalTrials.gov Identifier:   NCT00003022
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma  
childhood supratentorial ependymoma  
adult myxopapillary ependymoma  
adult anaplastic ependymoma  
recurrent childhood ependymoma  
metastatic osteosarcoma  
recurrent childhood rhabdomyosarcoma  
regional neuroblastoma  
disseminated neuroblastoma  
stage 4S neuroblastoma  
recurrent neuroblastoma
retinoblastoma
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

Study placed in the following topic categories:
Retinal Neoplasms
Thoracic Neoplasms
Glioblastoma
Meningeal Neoplasms
Neuroectodermal Tumors, Primitive
Ewing's family of tumors
Malignant mesenchymal tumor
Central Nervous System Neoplasms
Retinoblastoma
Osteogenic sarcoma
Soft tissue sarcomas
Neuroblastoma
Ependymoma
Melanoma
Antibodies, Monoclonal
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Uveal melanoma
Sarcoma, Ewing's
Lung Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Eye Diseases
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Nevi and Melanomas
Neoplasms, Neuroepithelial

Source: National Library of Medicine (NLM) July 02, 2008