NCT00445965 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Six-month Overall Survival

Source null

→

primary · POSTED

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.

Source null

→

secondary · POSTED

Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-ovarian-neoplasm
nct id: NCT00445965
trial label: Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
outcome key
om-0000
source section id
NCT00445965-om-0000
source outcome index
0
endpoint
Six-month Overall Survival
endpoint definition
Six-month Overall Survival
time origin
6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
outcome key
om-0001
source section id
NCT00445965-om-0001
source outcome index
1
endpoint
Number of Participants With Response at 6 Months
endpoint definition
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.
time origin
6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
outcome key
om-0002
source section id
NCT00445965-om-0002
source outcome index
2
endpoint
Number of Participants Evaluable for Toxicities
endpoint definition
Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).
time origin
1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
outcome key
om-0000
arm key
OG000
arm label
131I-3F8
regimen
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. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-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.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00445965-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
outcome key
om-0001
arm key
OG000
arm label
131I-3F8
regimen
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. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-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.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00445965-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
outcome key
om-0002
arm key
OG000
arm label
131I-3F8
regimen
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. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-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.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00445965-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00445965
harm key
EG000
source section id
NCT00445965-ae
event group key
EG000
event group label
131I-3F8
serious affected
39
serious at risk
78
other affected
78
other at risk
78
frequency threshold
0
collection period
1 year
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice