CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
cisplatin +5 moredrug
Likely dose
Iodine I-131 monoclonal antibody 3F8 as radioimmunotherapy with reduced-dose craniospinal radiation therapy and IMRT boost; cisplatin, lomustine, and vincristine sulfate chemotherapyAI-extracted
Key inclusion· 9
  • Histologic confirmation of medulloblastoma by Memorial Sloan-Kettering Cancer Center pathology
  • Age ≥3 years old
  • Post-operative residual tumor ≤1.5 cm² on head MRI
  • No leptomeningeal dissemination (Chang stage M-0) on head/spine MRI and lumbar CSF cytology
Key exclusion· 11
  • Age less than 3 years
  • Residual tumor >1.5 cm² on post-operative head MRI
  • Evidence of leptomeningeal dissemination on imaging or CSF cytology positive
  • Evidence of extra-neural metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00058370
NCT00058370N/ACompleted

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

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 9, 2003·Updated May 11, 2020

In Brief

A clinical study evaluating cisplatin, lomustine, and 4 other interventions for Brain and Central Nervous System Tumors. Completed, enrolled 6 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartFeb 1, 2003
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 16.3 yearsPosted 23.2 years ago

Interventions

cisplatindrug

lomustinedrug

vincristine sulfatedrug

adjuvant therapyprocedure

iodine I 131 monoclonal antibody 3F8radiation

radiation therapyradiation