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Phase II Pilot Study of Post-Operative Intrathecal Radioimmunotherapy, Reduced-Dose Craniospinal Radiotherapy With Intensity-Modulated Radiotherapy Boost, and Chemotherapy in Patients With Standard-Risk Medulloblastoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Active
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3 and over
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NCI
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MSKCC-02088
NCT00058370
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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.
Entry Criteria Disease Characteristics:
- Histologically confirmed medulloblastoma
- Neurosurgical resection of the tumor within the past 42 days
- No more than 1.5 cm2 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)
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - No prior chemotherapy for medulloblastoma
Endocrine therapy Radiotherapy - No prior radiotherapy for medulloblastoma
Surgery - See Disease Characteristics
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic 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
Expected Enrollment 20A total of 6-20 patients will be accrued for this study within 3.2 years. Outcomes Primary Outcome(s)Feasibility
Progression-free survival
Morbidity
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.
Trial Contact Information
Trial Lead Organizations Memorial Sloan-Kettering Cancer Center | | | | Ira Dunkel, MD, Protocol chair | | | |
Trial Sites
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| New York |
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New York |
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| | | | | | | | | Memorial Sloan-Kettering Cancer Center |
| | | Ira Dunkel, MD | | Ph: | 212-639-2153 | | 800-525-2225 |
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dunkeli@mskcc.org |
| | | Kim Kramer, MD | | Ph: | 212-639-6410 | | 800-525-2225 |
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kramerk@mskcc.org |
| | | Suzanne Wolden, MD | | Ph: | 212-639-5148 | | 800-525-2225 |
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| | Email:
woldens@mskcc.org |
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| Registry Information | | | Official Title | | A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma | | | Trial Start Date | | 2002-10-22 | | | Trial Completion Date | | 2009-10-22 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00058370 | | | Date Submitted to PDQ | | 2003-02-28 | | | Information Last Verified | | 2008-09-08 | | | NCI Grant/Contract Number | | P30-CA08748 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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