Trial Outcomes & Findings for Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer (NCT NCT00445965)

NCT ID: NCT00445965

Last Updated: 2024-04-04

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

6 months

Results posted on

2024-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	131I-3F8 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.
Overall Study STARTED	78
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	131I-3F8 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.
Overall Study Adverse Event	2
Overall Study Physician Decision	1
Overall Study Enrolled but not treated	1
Overall Study Removed due to progressive disease	29

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	131I-3F8 n=78 Participants 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.
Age, Continuous	10 years n=99 Participants
Sex: Female, Male Female	34 Participants n=99 Participants
Sex: Female, Male Male	44 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants
Race (NIH/OMB) White	63 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Region of Enrollment United States	78 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	131I-3F8 n=78 Participants 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.
Six-month Overall Survival Participants still alive at the 6-month mark	67 Participants
Six-month Overall Survival Participants not alive at the 6-month mark	11 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	131I-3F8 n=78 Participants 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.
Number of Participants With Response at 6 Months Complete Response	31 Participants
Number of Participants With Response at 6 Months Stable Disease	8 Participants
Number of Participants With Response at 6 Months Progression of Disease	21 Participants
Number of Participants With Response at 6 Months Not Evaluable	18 Participants

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Outcome measures
Measure	131I-3F8 n=78 Participants 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.
Number of Participants Evaluable for Toxicities Not evaluable for toxicities, participant was not treated	1 Participants
Number of Participants Evaluable for Toxicities Evaluable for toxicities	77 Participants

Adverse Events

131I-3F8

Serious events: 39 serious events

Other events: 78 other events

Deaths: 54 deaths

Serious adverse events

Serious adverse events
Measure	131I-3F8 n=78 participants at risk 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.
Investigations ALT, SGPT	1.3% 1/78 • 1 year
Investigations Bilirubin	1.3% 1/78 • 1 year
Psychiatric disorders Confusion	1.3% 1/78 • 1 year
Metabolism and nutrition disorders Dehydration	1.3% 1/78 • 1 year
General disorders Fatigue	1.3% 1/78 • 1 year
General disorders Fever	7.7% 6/78 • 1 year
Gastrointestinal disorders Gastrointestinal, other	1.3% 1/78 • 1 year
Vascular disorders Hypertension	2.6% 2/78 • 1 year
Infections and infestations Inf norm ANC/gr1/2 neut-	2.6% 2/78 • 1 year
Infections and infestations Infection, other	3.8% 3/78 • 1 year
Injury, poisoning and procedural complications Injection site reaction/extravasation	1.3% 1/78 • 1 year
Investigations Lipase	1.3% 1/78 • 1 year
Investigations Lymphopenia	1.3% 1/78 • 1 year
Gastrointestinal disorders Nausea	1.3% 1/78 • 1 year
Nervous system disorders Nerology - Other	2.6% 2/78 • 1 year
Nervous system disorders Neuropathy: sensory	1.3% 1/78 • 1 year
Investigations Neutrophils/granulocytes (ANC/AGC)	1.3% 1/78 • 1 year
Musculoskeletal and connective tissue disorders Pain - bone	1.3% 1/78 • 1 year
Nervous system disorders Pain - Head/headache	6.4% 5/78 • 1 year
General disorders Pain - other	2.6% 2/78 • 1 year
Investigations Platelets	3.8% 3/78 • 1 year
Metabolism and nutrition disorders Hypokalemia	2.6% 2/78 • 1 year
Psychiatric disorders Psychosis	1.3% 1/78 • 1 year
Nervous system disorders Seizure	1.3% 1/78 • 1 year
Cardiac disorders Sinus bradycardia	1.3% 1/78 • 1 year
Metabolism and nutrition disorders Hyponatremia	1.3% 1/78 • 1 year
Nervous system disorders Somnolence	2.6% 2/78 • 1 year
Eye disorders Vision-blurred vision	1.3% 1/78 • 1 year
Gastrointestinal disorders Vomiting	5.1% 4/78 • 1 year

Other adverse events

Other adverse events
Measure	131I-3F8 n=78 participants at risk 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.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 26/78 • 1 year
Investigations Alkaline phosphatase	10.3% 8/78 • 1 year
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.3% 1/78 • 1 year
Investigations ALT, SGPT	80.8% 63/78 • 1 year
Investigations Amylase	3.8% 3/78 • 1 year
Investigations AST, SGOT	70.5% 55/78 • 1 year
Investigations Bicarbonate, serum-low	1.3% 1/78 • 1 year
Investigations Hyperbilirubinemia	12.8% 10/78 • 1 year
Metabolism and nutrition disorders Hypercalcemia	5.1% 4/78 • 1 year
Investigations Cholesterol high	2.6% 2/78 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/78 • 1 year
General disorders Fever	7.7% 6/78 • 1 year
Metabolism and nutrition disorders Hyperglycemia	98.7% 77/78 • 1 year
Metabolism and nutrition disorders Hypoglycemia	19.2% 15/78 • 1 year
Blood and lymphatic system disorders Hemoglobin	98.7% 77/78 • 1 year
Vascular disorders Hypertension	3.8% 3/78 • 1 year
Investigations INR	14.1% 11/78 • 1 year
Investigations Leukocytes	98.7% 77/78 • 1 year
Investigations Lymphopenia	98.7% 77/78 • 1 year
Metabolism and nutrition disorders Hypomagnesemia	16.7% 13/78 • 1 year
Musculoskeletal and connective tissue disorders Muscle weakness - Extremity - lower	1.3% 1/78 • 1 year
Gastrointestinal disorders Nausea	6.4% 5/78 • 1 year
Investigations Neutrophils/granulocytes	98.7% 77/78 • 1 year
Nervous system disorders Pain - head/headache	3.8% 3/78 • 1 year
Investigations Platelets	98.7% 77/78 • 1 year
Metabolism and nutrition disorders Hyperkalemia	10.3% 8/78 • 1 year
Metabolism and nutrition disorders Hypokalemia	53.8% 42/78 • 1 year
Investigations PTT	19.2% 15/78 • 1 year
Cardiac disorders Sinus bradycardia	1.3% 1/78 • 1 year
Cardiac disorders Sinus tachycardia	1.3% 1/78 • 1 year
Metabolism and nutrition disorders Hypernatremia	7.7% 6/78 • 1 year
Metabolism and nutrition disorders Hyponatremia	26.9% 21/78 • 1 year
Nervous system disorders Tremor	1.3% 1/78 • 1 year
Gastrointestinal disorders Vomiting	10.3% 8/78 • 1 year
Nervous system disorders Somnolence	1.3% 1/78 • 1 year
Skin and subcutaneous tissue disorders Pruritus	1.3% 1/78 • 1 year
Metabolism and nutrition disorders Hypophosphatemia	16.7% 13/78 • 1 year
General disorders Pain	1.3% 1/78 • 1 year
Investigations Lipase	2.6% 2/78 • 1 year
Vascular disorders Hypotension	1.3% 1/78 • 1 year
Metabolism and nutrition disorders Dehydration	1.3% 1/78 • 1 year
Gastrointestinal disorders Gastrointestinal, other	1.3% 1/78 • 1 year

Additional Information

Dr. Kim Kramer MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-6410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place