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

Condition(s) targeted: Brain and Central Nervous System Tumors

Intervention: cisplatin (Drug); lomustine (Drug); vincristine sulfate (Drug); adjuvant therapy (Procedure); iodine I 131 monoclonal antibody 3F8 (Radiation); radiation therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Memorial Sloan-Kettering Cancer Center

Official(s) and/or principal investigator(s):
Ira Dunkel, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center

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.

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 design: Primary Purpose: Treatment

Primary outcome:

Feasibility

Progression-free survival

Morbidity

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.

Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed medulloblastoma

- Neurosurgical resection of the tumor within the past 42 days

- No more than 1. 5 cm^2 of residual tumor by MRI

- No extraneural metastatic disease

- No definitive evidence of leptomeningeal dissemination (Chang stage M-0) by head and

spine MRI and lumbar cerebrospinal fluid (CSF) cytology

- Adequate CSF flow (defined as lack of compartmentalization) required on an indium In

111 pentetic acid flow study

- No signs or symptoms of increased intracranial pressure (e. g., headache, emesis, or

ocular paresis)

PATIENT CHARACTERISTICS:

Age

- 3 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Bilirubin less than 2. 0 mg/dL

- AST less than 3 times upper limit of normal

Renal

- Creatinine clearance OR nuclear glomerular filtration rate at least 70 mL/min

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for medulloblastoma

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for medulloblastoma

Surgery

- See Disease Characteristics

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Contact Person, Phone: 212-305-9327

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Ira Dunkel, MD, Phone: 212-639-2153, Email: dunkeli@mskcc.org

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2003
Last updated: July 7, 2009