CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
DNA analysis +4 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00445965
NCT00445965Phase 2Completed

Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms

Memorial Sloan Kettering Cancer Center·interventional·Posted Mar 9, 2007·Updated Apr 4, 2024

In Brief

A Phase 2 clinical trial evaluating DNA analysis, immunologic technique, and 3 other interventions for Brain and Central Nervous System Tumors and 9 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal metastases. PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2007
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 17.1 yearsPosted 19.3 years ago

Interventions

DNA analysisgenetic

immunologic techniqueother

pharmacological studyother

iodine I 131 monoclonal antibody 3F8radiation

131I-3F8radiation

Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.