Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
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|ClinicalTrials.gov Identifier: NCT00445965|
Recruitment Status : Active, not recruiting
First Posted : March 9, 2007
Last Update Posted : January 17, 2018
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal metastases.
PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Metastatic Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma Small Intestine Cancer||Genetic: DNA analysis Other: immunologic technique Other: pharmacological study Radiation: iodine I 131 monoclonal antibody 3F8 Radiation: 131I-3F8||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms|
|Actual Study Start Date :||January 2006|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease.
Genetic: DNA analysis
Other: immunologic technique
Other: pharmacological study
Radiation: iodine I 131 monoclonal antibody 3F8
Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
- Six-month overall survival [ Time Frame: 6 months ]
- response rate [ Time Frame: 6 months ]A "response" is defined as a patient being alive six months after their first treatment.
- cumulative toxicities [ Time Frame: 1 year ]Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445965
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Study Chair:||Kim Kramer, MD||Memorial Sloan Kettering Cancer Center|