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

Completed · Not applicable

Conditions studied: Brain and Central Nervous System Tumors

In brief

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.

Key facts

Study ID

NCT00058370

Run by

Memorial Sloan Kettering Cancer Center

People needed

6

Starts

2003-02-01

Expected to finish

2019-06-01

Last updated by the study team

2020-05-11

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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