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A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma


N/A
3 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ira Dunkel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

02-088

NCT ID:

NCT00058370

Start Date:

February 2003

Completion Date:

February 2013

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult medulloblastoma
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032