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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on August 4, 2004.   Last Updated on March 18, 2011   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00089245
  Purpose

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.

PURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled monoclonal antibody therapy in treating patients with refractory, recurrent, or advanced CNS or leptomeningeal metastases.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Neuroblastoma
Sarcoma
Radiation: iodine I 131 monoclonal antibody 8H9
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms

Resource links provided by NLM:


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

Estimated Enrollment: 80
Study Start Date: July 2004
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of intrathecal iodine I 131 monoclonal antibody 8H9 in patients with refractory, recurrent, or advanced CNS or leptomeningeal cancer.
  • Determine the clinical toxic effects of this drug in these patients.
  • Correlate tumor response by MRI with CSF reverse-transcription polymerase chain reaction in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive iodine I 131 monoclonal antibody 8H9 (^131I MOAB 8H9)* intrathecally on day 1. Treatment repeats every 4 weeks for up to 2 courses (total of 2 injections) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ^131I MOAB 8H9 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

NOTE: *Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at a stablished dose. Neuroblastoma patients can be treated at the stablished dose with or without stored stem cells.

PROJECTED ACCRUAL: A total of 3-80 patients will be accrued for this study within 2-3 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed CNS or leptomeningeal cancer, meeting 1 of the following criteria:

    • Refractory to conventional therapy OR for which no conventional therapy exists

      • Less than 10% chance of cure with conventional therapy
    • Recurrent brain tumor or other solid tumor with a predilection for leptomeningeal dissemination, including, but not limited to, the following:

      • Medulloblastoma
      • Ewing's sarcoma/primitive neuroectodermal tumor
      • Rhabdoid tumor
      • Neuroblastoma
      • Osteosarcoma
      • Desmoplastic small rounded-cell tumor
      • Rhabdomyosarcoma
  • 8H9 reactivity confirmed by immunohistochemical staining or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma
  • No rapidly progressing or deteriorating neurologic examination

    • Stable neurological deficits as a result of brain tumor allowed
  • No obstructive or symptomatic communicating hydrocephalus

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • No hepatic toxicity ≥ grade 2

Renal

  • No renal toxicity ≥ grade 2

Cardiovascular

  • No cardiac toxicity ≥ grade 2

Pulmonary

  • No pulmonary toxicity ≥ grade 2

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Concurrent active malignancy outside the CNS allowed
  • No uncontrolled life-threatening infection
  • No gastrointestinal system toxicity ≥ grade 2
  • No other severe major organ toxicity

    • Hearing loss ≤ grade 3

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 3 weeks since prior systemic chemotherapy

Endocrine therapy

  • Prior corticosteroids allowed

Radiotherapy

  • At least 3 weeks since prior cranial or spinal radiotherapy

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089245

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kim Kramer, MD     212-639-6410     kramerk@mskcc.org    
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Kim Kramer, MD Memorial Sloan-Kettering Cancer Center
Investigator: Nai-Kong V. Cheung, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00089245     History of Changes
Other Study ID Numbers: CDR0000378183, MSKCC-03133
Study First Received: August 4, 2004
Last Updated: March 18, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
leptomeningeal metastases
recurrent neuroblastoma
disseminated neuroblastoma
recurrent adult brain tumor
recurrent childhood medulloblastoma
recurrent childhood rhabdomyosarcoma
recurrent childhood soft tissue sarcoma
recurrent osteosarcoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
childhood atypical teratoid/rhabdoid tumor
adult medulloblastoma
previously treated childhood rhabdomyosarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic osteosarcoma
childhood desmoplastic small round cell tumor
metastatic childhood soft tissue sarcoma
adult rhabdomyosarcoma
recurrent adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Neuroblastoma
Central Nervous System Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Meningeal Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012