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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cisplatin
lomustine
vincristine sulfate
adjuvant therapy
iodine I 131 monoclonal antibody 3F8
radiation therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult medulloblastoma, untreated childhood medulloblastoma

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

histologic proof of medulloblastoma

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility
Progression-free Survival
Morbidity

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
April 28, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058370
Brief Title
Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma
Official Title
A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2003 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult medulloblastoma, untreated childhood medulloblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
histologic proof of medulloblastoma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
lomustine
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
iodine I 131 monoclonal antibody 3F8
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Feasibility
Time Frame
2 years
Title
Progression-free Survival
Time Frame
2 years
Title
Morbidity
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Dunkel, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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