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Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003022
  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
Radiation: iodine I 131 monoclonal antibody 3F8
Phase I

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

Resource links provided by NLM:


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
Investigators
Study Chair: Kim Kramer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000065607, MSKCC-97021, NCI-G97-1267
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003022     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic osteosarcoma
childhood infratentorial ependymoma
recurrent childhood rhabdomyosarcoma
childhood supratentorial ependymoma
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
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

Study placed in the following topic categories:
Thoracic Neoplasms
Retinal Neoplasms
Glioblastoma
Meningeal Neoplasms
Neuroectodermal Tumors, Primitive
Central Nervous System Neoplasms
Retinoblastoma
Neoplasms, Connective and Soft Tissue
Lung Neoplasms
Iodine
Neuroepithelioma
Osteogenic Sarcoma
Glioma
Nervous System Neoplasms
Immunoglobulins
Rhabdomyosarcoma
Eye Neoplasms
Astrocytoma
Ewing's Sarcoma
Carcinoma, Small Cell
Brain Neoplasms
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
Brain Stem Glioma, Childhood
Lung Diseases
Sarcoma
Nevus
Neoplasms, Glandular and Epithelial
Immunologic Factors
Uveal Melanoma

Additional relevant MeSH terms:
Retinal Neoplasms
Thoracic Neoplasms
Meningeal Neoplasms
Neuroectodermal Tumors, Primitive
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Retinoblastoma
Neuroblastoma
Melanoma
Antibodies, Monoclonal
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Retinal Diseases
Nervous System Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Nervous System Diseases
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Antibodies
Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009