ClinicalTrials.gg
Sign In
CompletedNCT00058370Updated May 11, 2020Results posted

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

An interventional study of cisplatin and lomustine in Brain and Central Nervous System Tumors, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 2 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2020-05-11.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
3 Years and older
Sex
All
01

Study summary

RATIONALE: Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy may kill any tumor cells remaining after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients who have undergone surgery for medulloblastoma.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of combining post-operative intrathecal radioimmunotherapy, craniospinal radiotherapy with intensity-modulated radiotherapy boost, and chemotherapy in patients with standard-risk medulloblastoma.
  • Determine whether this regimen can maintain or exceed the current progression-free survival rate while decreasing long-term serious morbidity in these patients.
  • Determine the long-term morbidities, most specifically neuropsychological, neuroendocrine, audiometric, and growth outcomes, in patients treated with this regimen.

OUTLINE:

  • Radioimmunotherapy: Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 on days 1 and 8.
  • Radiotherapy: Beginning as soon as possible after radioimmunotherapy, patients undergo external-beam and intensity-modulated radiotherapy 5 days a week for 6 weeks.
  • Chemotherapy: Patients receive vincristine IV once weekly for 8 weeks concurrently with radiotherapy. Beginning about 6 weeks after completion of radiotherapy (4 weeks after vincristine), patients receive cisplatin IV over 6 hours and oral lomustine on day 0 and vincristine IV on days 0, 7, and 14. Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study within 3.2 years.

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • adult medulloblastoma
  • untreated childhood medulloblastoma
03

In context

Central Nervous System Neoplasms

684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's enrollment of 6 is below the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.

Browse Memorial Sloan Kettering Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have histologic proof of medulloblastoma reviewed by the Department of Pathology at the Memorial Sloan-Kettering Cancer Center.
  • Patients must begin study prescribed therapy within 42 days of neurosurgical resection of the tumor
  • Age ≥ 3-years-old. Post-operative head MRI must confirm ≤ 1.5 cm2 of residual tumor is present.
  • Head and spine MRI and lumbar CSF cytology must not show any definitive evidence of leptomeningeal dissemination (Chang stage M-0).
  • Examinations evaluating extra-neural sites will not be mandated, but any performed for clinical indications must be free of metastatic disease.
  • No prior RT or chemotherapy for the medulloblastoma is permitted Patients must have adequate CSF flow (defined as lack of compartmentalization) on an 111-Indium DTPA flow study.
  • Patients must have adequate organ function as defined by:
  • Hepatic: total bilirubin \< 2.0 mg/dl, AST \< 3 x the upper limit of normal.
  • Renal: Calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m\^2.
  • The patient, or for minors, a parent or legal guardian, must give informed written consent indicating they are aware of the investigational nature of this study.

Exclusion criteria

EXCLUSION CRITERIA:

  • Unable to start study prescribed therapy within 42 days of neurosurgical resection of the tumor
  • Age less than 3 years > 1.5 cm2 residual tumor on post-operative head MRI
  • Evidence of leptomeningeal dissemination on head or spine MRI or CSF cytology positivity
  • Evidence of extra-neural metastases
  • Prior radiation therapy or chemotherapy for the medulloblastoma
  • Inadequate CSF flow on 111-Indium DTPA flow study Patients with signs or symptoms suggestive of increased intracranial pressure (headache, emesis, ocular paresis) will not be eligible until they are cleared by neurology and/or neurosurgery.
  • Pregnancy
  • Total bilirubin ≥ 2.0 mg/dl
  • AST ≥ 3 x the upper limit of normal
  • Creatinine clearance and GFR \< 70 ml/min/1.73 m\^2
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    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.

    Drug: cisplatin · Drug: lomustine · Drug: vincristine sulfate · Procedure: adjuvant therapy · Radiation: iodine I 131 monoclonal antibody 3F8 · Radiation: radiation therapy

Interventions

06

What researchers measure

Primary outcomes

  1. Feasibility

    Time frame: 2 years

  2. Progression-free Survival

    Time frame: 2 years

  3. Morbidity

    Time frame: 2 years

07

Results

Posted May 11, 2020

Participant flow

Participant flow — Overall Study
MilestoneHistologic Proof of Medulloblastoma
Started6
Completed6
Not completed0

Outcome measures

PrimaryFeasibility
Time frame:
2 years

No measurements were reported for this outcome.

PrimaryProgression-free Survival
Time frame:
2 years

No measurements were reported for this outcome.

PrimaryMorbidity
Time frame:
2 years
Reported as:
Count of participants · Participants
Morbidity
ParticipantsHistologic Proof of Medulloblastoma
Deceased3
Alive3

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Histologic Proof of Medulloblastoma3/6 (50%)2/6 (33.3%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventHistologic Proof of Medulloblastoma
Infection w.out neutropeniaInfections and infestations2/6
ConstipationGastrointestinal disorders1/6
FeverGeneral disorders1/6
LeukocytesInvestigations1/6
LymphopeniaInvestigations1/6
Neutrophils/granInvestigations1/6
Most frequent other events
Showing 10 of 28
Most frequent other events
EventHistologic Proof of Medulloblastoma
NauseaGastrointestinal disorders4/6
FatigueGeneral disorders3/6
VomitingGastrointestinal disorders3/6
AlopeciaSkin and subcutaneous tissue disorders2/6
AnorexiaMetabolism and nutrition disorders2/6
Bone painMusculoskeletal and connective tissue disorders2/6
FeverGeneral disorders2/6
HeadacheNervous system disorders2/6
Pain, otherGeneral disorders2/6
Stomatitis/pharynGastrointestinal disorders2/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Histologic Proof of Medulloblastoma
Median6 (4 to 10)
Sex: Female, Male
Sex: Female, Male(Participants)Histologic Proof of Medulloblastoma
Female3
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Histologic Proof of Medulloblastoma
Hispanic or Latino0
Not Hispanic or Latino6
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Histologic Proof of Medulloblastoma
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White6
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Histologic Proof of Medulloblastoma
United States6
08

Study locations

2 sites
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
    New York, New York 10032, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 26, 2008

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00058370
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 9, 2003
Start date
Feb 2003
Primary completion
Jun 2019
Completion
Jun 2019
Results posted
May 11, 2020
Last update
May 11, 2020

Study contacts

Ira Dunkel, MD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Cisplatin · Lomustine · Vincristine

Other studies in this condition

Central Nervous System Neoplasms →

Other studies from this sponsor

Memorial Sloan Kettering Cancer Center →

Start the discussion