Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms
N/A
N/A
Both
Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer, Melanoma (Skin), Metastatic Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma, Small Intestine Cancer
Trial Information
Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms
OBJECTIVES:
- Determine if intrathecal iodine I 131 monoclonal antibody 3F8 activity in patients with
GD2-expressing central nervous system or leptomeningeal neoplasms is sufficiently
promising (i.e., 6-month overall survival rate ≥ 25%) to warrant further study.
- Determine the response rate in patients treated with this drug.
- Determine the cumulative toxicities of this drug in these patients.
- Describe the effects of human-antimouse antibody on cerebrospinal fluid and serum
pharmacokinetics in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 for dosimetry. Beginning
approximately 1 week later, patients receive intrathecal iodine I 131 monoclonal antibody
3F8 on day 1. Treatment intrathecal iodine I 131 monoclonal antibody 3F8 repeats weekly for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood and cerebrospinal fluid samples are collected prior to and after administration of
each course of study drug. Samples are analyzed to assess the intrathecal and blood
pharmacokinetics of iodine I 131 monoclonal antibody 3F8 and serum human antimouse
antibodies. Samples are also analyzed in tumor genetic studies.
After completion of study treatment, patients are followed periodically for 3 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed GD2-expressing malignancy, including the following:
- Medulloblastoma or primitive neuroectodermal tumor of the CNS
- High-grade astrocytoma
- Malignant glioma
- Neuroblastoma
- Retinoblastoma
- Ependymoma
- Rhabdoid tumors
- Sarcomas
- Melanoma
- Small cell lung carcinoma
- Desmoplastic small round cell tumor
- Other tumor types with GD2 expression confirmed by immunohistochemical staining
and assessed by the Memorial Sloan-Kettering Department of Pathology using prior
frozen tissue, bone marrow, or cerebrospinal fluid cytology
- Must meet 1 of the following criteria:
- Refractory to conventional therapies
- Disease for which no conventional therapy exists
- Recurrent brain tumors with a predilection for leptomeningeal dissemination
(e.g., medulloblastoma, supratentorial primitive neuroectodermal tumor, rhabdoid
tumor)
- Patients with active malignancy outside the central nervous system are eligible
- No obstructive or symptomatic communicating hydrocephalus
PATIENT CHARACTERISTICS:
- Absolute neutrophil count > 1,000/mm³
- Platelet count > 50,000/mm³
- No uncontrolled life-threatening infection
- No rapidly progressing or deteriorating neurologic examination
- No severe major organ toxicity (i.e., renal, cardiac, hepatic, pulmonary, and
gastrointestinal system toxicity ≤ grade 2)
- Stable neurological deficits (due to brain tumor) allowed
- No hearing loss > 3
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No cranial or spinal irradiation within the past 3 weeks
- No prior craniospinal radiation > 45 Gy or focal brain radiation > 72 Gy
- No systemic chemotherapy within the past 3 weeks (corticosteroids allowed)
- Programmable shunt allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Six-month overall survival
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Kim Kramer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
05-122
NCT ID:
NCT00445965
Start Date:
January 2006
Completion Date:
January 2014
Related Keywords:
- Brain and Central Nervous System Tumors
- Intraocular Melanoma
- Lung Cancer
- Melanoma (Skin)
- Metastatic Cancer
- Neuroblastoma
- Ovarian Cancer
- Retinoblastoma
- Sarcoma
- Small Intestine Cancer
- recurrent childhood medulloblastoma
- untreated childhood medulloblastoma
- adult supratentorial primitive neuroectodermal tumor (PNET)
- recurrent childhood supratentorial primitive neuroectodermal tumor
- untreated childhood supratentorial primitive neuroectodermal tumor
- adult anaplastic astrocytoma
- adult diffuse astrocytoma
- adult pilocytic astrocytoma
- adult subependymal giant cell astrocytoma
- recurrent childhood subependymal giant cell astrocytoma
- untreated childhood subependymal giant cell astrocytoma
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- untreated childhood cerebellar astrocytoma
- adult brain stem glioma
- adult mixed glioma
- childhood mixed glioma
- recurrent childhood brain stem glioma
- recurrent childhood visual pathway and hypothalamic glioma
- recurrent childhood visual pathway glioma
- untreated childhood brain stem glioma
- untreated childhood visual pathway and hypothalamic glioma
- untreated childhood visual pathway glioma
- regional neuroblastoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- extraocular retinoblastoma
- recurrent retinoblastoma
- adult anaplastic ependymoma
- adult ependymoblastoma
- adult ependymoma
- adult myxopapillary ependymoma
- adult subependymoma
- childhood infratentorial ependymoma
- childhood supratentorial ependymoma
- recurrent childhood ependymoma
- childhood atypical teratoid/rhabdoid tumor
- recurrent melanoma
- stage IV melanoma
- adult medulloblastoma
- chondrosarcoma
- metastatic osteosarcoma
- recurrent osteosarcoma
- metastatic childhood soft tissue sarcoma
- ovarian sarcoma
- recurrent childhood soft tissue sarcoma
- stage III adult soft tissue sarcoma
- stage IV adult soft tissue sarcoma
- stage III uterine sarcoma
- stage IV uterine sarcoma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- adult anaplastic oligodendroglioma
- adult desmoplastic small round cell tumor
- adult oligodendroglioma
- adult giant cell glioblastoma
- adult gliosarcoma
- tumors metastatic to brain
- adult rhabdomyosarcoma
- childhood oligodendroglioma
- childhood desmoplastic small round cell tumor
- extensive stage small cell lung cancer
- intraocular retinoblastoma
- recurrent adult brain tumor
- recurrent adult soft tissue sarcoma
- recurrent uterine sarcoma
- small intestine leiomyosarcoma
- recurrent small intestine cancer
- recurrent small cell lung cancer
- extraocular extension melanoma
- recurrent intraocular melanoma
- metastatic intraocular melanoma
- iris melanoma
- ciliary body and choroid melanoma, medium/large size
- newly diagnosed childhood ependymoma
- adult glioblastoma
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent childhood pineoblastoma
- untreated childhood pineoblastoma
- adult pineal gland astrocytoma
- stage IIIA melanoma
- stage IIIB melanoma
- stage IIIC melanoma
- recurrent childhood anaplastic astrocytoma
- untreated childhood anaplastic astrocytoma
- recurrent childhood anaplastic oligoastrocytoma
- recurrent childhood anaplastic oligodendroglioma
- untreated childhood anaplastic oligoastrocytoma
- untreated childhood anaplastic oligodendroglioma
- recurrent childhood giant cell glioblastoma
- recurrent childhood glioblastoma
- untreated childhood giant cell glioblastoma
- untreated childhood glioblastoma
- recurrent childhood gliosarcoma
- untreated childhood gliosarcoma
- recurrent childhood gliomatosis cerebri
- untreated childhood gliomatosis cerebri
- childhood high-grade cerebellar astrocytoma
- childhood high-grade cerebral astrocytoma
- Lung Neoplasms
- Melanoma
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Nervous System Neoplasms
- Neuroblastoma
- Ovarian Neoplasms
- Retinoblastoma
- Central Nervous System Neoplasms
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Astrocytoma
- Neuroectodermal Tumors, Primitive
- Uveal Neoplasms
- Desmoplastic Small Round Cell Tumor
- Intestinal Neoplasms
- Neuroectodermal Tumors, Primitive, Peripheral
- Meningeal Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
