NCT00058370

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 11, 2020

Completed
Last Updated

May 11, 2020

Status Verified

June 1, 2019

Enrollment Period

16.3 years

First QC Date

April 7, 2003

Results QC Date

April 28, 2020

Last Update Submit

April 28, 2020

Conditions

Brain and Central Nervous System Tumors

Keywords

adult medulloblastomauntreated childhood medulloblastoma

Outcome Measures

Primary Outcomes (3)

  • Feasibility

    2 years

  • Progression-free Survival

    2 years

  • Morbidity

    2 years

Study Arms (1)

histologic proof of medulloblastoma

EXPERIMENTAL

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: cisplatinDrug: lomustineDrug: vincristine sulfateProcedure: adjuvant therapyRadiation: iodine I 131 monoclonal antibody 3F8Radiation: radiation therapy

Interventions

cisplatinDRUG
histologic proof of medulloblastoma
lomustineDRUG
histologic proof of medulloblastoma
vincristine sulfateDRUG
histologic proof of medulloblastoma
adjuvant therapyPROCEDURE
histologic proof of medulloblastoma
iodine I 131 monoclonal antibody 3F8RADIATION
histologic proof of medulloblastoma
radiation therapyRADIATION
histologic proof of medulloblastoma

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsMedulloblastoma

Interventions

CisplatinLomustineVincristineChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCombined Modality TherapyTherapeuticsDrug Therapy

Results Point of Contact

Title
Dr. Ira Dunkel, MD
Organization
Memorial Sloan Kettering Cancer Center
dunkeli@mskcc.org
212-639-2153

Study Officials

  • Ira Dunkel, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

February 1, 2003

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

May 11, 2020

Results First Posted

May 11, 2020

Record last verified: 2019-06

Locations

US(2)