Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058370

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: cisplatin Drug: iodine I 131 monoclonal antibody 3F8 Drug: lomustine Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Vincristine sulfate Vincristine Cisplatin Iodine Cadexomer iodine Sodium iodide I 131 Immunoglobulins Globulin, Immune Lomustine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Morbidity [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2003
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058370

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Ira Dunkel, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Ira Dunkel )
Study ID Numbers:	CDR0000288826, MSKCC-02088
Study First Received:	April 7, 2003
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00058370
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult medulloblastoma
untreated childhood medulloblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors, Primitive
Lomustine
Vincristine
Central Nervous System Neoplasms
Antibodies, Monoclonal
Neuroectodermal Tumors
Antibodies
Cisplatin

Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Neuroepithelioma
Iodine
Glioma
Nervous System Neoplasms
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Mitosis Modulators

Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009