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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer
by
Barry Sugarman
on Tue 21 Feb 2006 04:03 PM PST | Permanent Link
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer http://www.clinicaltrials.gov/ct/show/NCT00089245?order=100 This study is currently recruiting patients. Verified by National Cancer Institute (NCI) August 2004 Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center 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 cancer. Condition Intervention Phase Adult Brain Tumor Drug: iodine I 131 monoclonal antibody 8H9 Phase I Adult Medulloblastoma Procedure: antibody therapy Adult Rhabdomyosarcoma Procedure: biological response modifier therapy Adult Soft Tissue Sarcoma Procedure: isotope therapy Childhood Medulloblastoma Procedure: monoclonal antibody therapy Childhood Rhabdoid Tumor of the Central Nervous System Procedure: radiation therapy Childhood Rhabdomyosarcoma Procedure: radioimmunotherapy Childhood Soft Tissue Sarcoma Desmoplastic Small Round-Cell Tumor Disseminated Neuroblastoma Leptomeningeal Metastases Metastatic Childhood Soft Tissue Sarcoma Metastatic Osteosarcoma Metastatic Tumors of the Ewing's Family Neuroblastoma Osteosarcoma Previously Treated Childhood Rhabdomyosarcoma Tumors of the Ewing's Family MedlinePlus related topics: Bone Cancer; Brain Cancer; Cancer; Cancer Alternative Therapies; Neuroblastoma; Neurologic Diseases; Soft Tissue Sarcoma Genetics Home Reference related topics: Cancer; Neurologic Diseases Study Type: Interventional Study Design: Treatment Official Title: Phase I Study of Intrathecal Iodine I 131 Monoclonal Antibody 8H9 in Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer Further study details as provided by National Cancer Institute (NCI): 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. * Determine the pharmacokinetics and dosimetry 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. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2-3 years. Eligibility Genders Eligible for Study: Both 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 * 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 Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00089245 New York Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting Clinical Trials Office for Memorial Sloan-Kettering Cancer Cen 646-227-2149 Study chairs or principal investigators Kim Kramer, MD, Study Chair, Memorial Sloan-Kettering Cancer Center More Information Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000378183; MSKCC-03133 Last Updated: February 7, 2006 Record first received: August 4, 2004 ClinicalTrials.gov Identifier: NCT00089245 Health Authority: United States: Federal Government ClinicalTrials.gov processed this record on 2006-02-21
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