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