Trial Outcomes & Findings for Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma (NCT NCT00058370)

NCT ID: NCT00058370

Last Updated: 2020-05-11

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

2 years

Results posted on

2020-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Histologic Proof of Medulloblastoma This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Histologic Proof of Medulloblastoma n=6 Participants This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
Age, Continuous	6 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	6 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 years

Population: No data were collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: Data were not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Histologic Proof of Medulloblastoma n=6 Participants This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
Morbidity Deceased	3 Participants
Morbidity Alive	3 Participants

Adverse Events

Histologic Proof of Medulloblastoma

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Histologic Proof of Medulloblastoma n=6 participants at risk This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
Gastrointestinal disorders Constipation	16.7% 1/6 • 1 year
General disorders Fever	16.7% 1/6 • 1 year
Infections and infestations Infection w.out neutropenia	33.3% 2/6 • 1 year
Investigations Leukocytes	16.7% 1/6 • 1 year
Investigations Lymphopenia	16.7% 1/6 • 1 year
Investigations Neutrophils/gran	16.7% 1/6 • 1 year

Other adverse events

Other adverse events
Measure	Histologic Proof of Medulloblastoma n=6 participants at risk This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
Gastrointestinal disorders Nausea	66.7% 4/6 • 1 year
General disorders Fatigue	50.0% 3/6 • 1 year
Gastrointestinal disorders Vomiting	50.0% 3/6 • 1 year
Skin and subcutaneous tissue disorders Alopecia	33.3% 2/6 • 1 year
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • 1 year
Musculoskeletal and connective tissue disorders Bone pain	33.3% 2/6 • 1 year
General disorders Fever	33.3% 2/6 • 1 year
Nervous system disorders Headache	33.3% 2/6 • 1 year
General disorders Pain, other	33.3% 2/6 • 1 year
Gastrointestinal disorders Stomatitis/pharyn	33.3% 2/6 • 1 year
Gastrointestinal disorders Abdominal pain/cramping	16.7% 1/6 • 1 year
Immune system disorders Allergic Reaction/Hyper	16.7% 1/6 • 1 year
Nervous system disorders Ataxia	16.7% 1/6 • 1 year
Gastrointestinal disorders Constipation	16.7% 1/6 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • 1 year
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • 1 year
Skin and subcutaneous tissue disorders Derm, skin other	16.7% 1/6 • 1 year
Gastrointestinal disorders Diarrhea (Pts w/out col)	16.7% 1/6 • 1 year
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • 1 year
Psychiatric disorders Mood alteration-anxiety	16.7% 1/6 • 1 year
Gastrointestinal disorders Mucositis/Rad	16.7% 1/6 • 1 year
Nervous system disorders Neuropathy-motor	16.7% 1/6 • 1 year
Nervous system disorders Neuropathy-sensory	16.7% 1/6 • 1 year
Eye disorders Ocular-Vision other	16.7% 1/6 • 1 year
Skin and subcutaneous tissue disorders Rash, desquamation	16.7% 1/6 • 1 year
Investigations SGOT (AST)	16.7% 1/6 • 1 year
Skin and subcutaneous tissue disorders Sweating	16.7% 1/6 • 1 year
Investigations Weight loss	16.7% 1/6 • 1 year

Additional Information

Dr. Ira Dunkel, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-2153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place