NCT00445965 · REGISTRY CONDITION SEARCH

Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-04-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Six-month Overall Survival

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outcome · POSTED

Number of Participants With Response at 6 Months

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outcome · POSTED

Number of Participants Evaluable for Toxicities

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of a malignancy known to expressGD2. Such tumors include medulloblastoma/primitive neuroectodermal tumor of the CNS, high grade astrocytomas, malignant glioma, neuroblastoma, retinoblastoma, ependymoma, rhabdoid tumors, sarcomas, melanoma or small cell lung carcinoma. For patients with other tumor types, GD2 expression must be confirmed by immunohistochemical staining and assessed by the Department of Pathology using prior frozen tissue, bone marrow or CSF cytology (send to Research Lab). * Patients must have CNS/ leptomeningeal disease including high risk medulloblastoma, or a CNS/leptomeningeal malignancy which is refractory to conventional therapies, or for which no conventional therapy exists, OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor). * Patients must have an absolute neutrophil count (ANC) \> 1000/ul and a platelet count \> 50,000/ul. * Patients may have active malignancy outside the central nervous system. * Patients who have a programmable shunt will not be excluded. * Both pediatric and adult patients of any age are eligible. * Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent. Exclusion Criteria: * Patients with obstructive or symptomatic communicating hydrocephalus. * Patients with an uncontrolled life-threatening infection. * Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period. * Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol. * Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol. * Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than or equal to grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with \<= 3 hearing loss are not excluded. * Patients must have no rapidly progressing or deteriorating neurologic examination. * Patients who have already received \>45 Gy to the craniospinal radiation or \>72 Gy focal brain radiation.
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Genetic: DNA analysis
Other: immunologic technique
Other: pharmacological study
Radiation: iodine I 131 monoclonal antibody 3F8
Radiation: 131I-3F8
label
131I-3F8
type
EXPERIMENTAL

interventions

arm Group Labels
131I-3F8
name
DNA analysis
type
GENETIC
arm Group Labels
131I-3F8
name
immunologic technique
type
OTHER
arm Group Labels
131I-3F8
name
pharmacological study
type
OTHER
arm Group Labels
131I-3F8
name
iodine I 131 monoclonal antibody 3F8
type
RADIATION
arm Group Labels
131I-3F8
description
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.
name
131I-3F8
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 78
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Six-month Overall Survival
time Frame
6 months
description
Complete Response (CR): Cytologic and radiographic CR will be evaluated separately, since patients with cytologic clearing and clinical response may continue to have residual abnormalities on MRI scans. Patients with a CR must also have stable or improved neurologic exam. Stable Disease (SD): Exists when a patient fails to fulfill the criteria for either complete or partial response or progressive disease. Progressive Disease (PD): An increase of at least 50% in the absolute number of malignant cells in the CSF OR, in -solid tumor patients, an increase of greater than 25% in the size of measurable lesions on MR scan OR the recurrence of malignant cells in the CSF or new lesions on MR after a patient has attained a complete remission OR evidence of clinical neurologic progression. New sites of or increasing evidence of leptomeningeal enhancement that is not "measurable" will also be considered evidence of disease progression.
measure
Number of Participants With Response at 6 Months
time Frame
6 months

secondary Outcomes

description
Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).
measure
Number of Participants Evaluable for Toxicities
time Frame
1 year

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

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query disease state id
ds-intraocular-uveal-melanoma-pediatric
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-intraocular-uveal-melanoma-000.json
source file sha256
78a8ac3d1a8ef6768805d5e697464b7eb6a18091aaa2ecfc0733b30adb771fb4
source json pointer
/studies/0/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
194a012309771711ac378e256dab13b259284c70d0e1eaa8f09830171bc7049f
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Childhood+Intraocular+%28Uveal%29+Melanoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice