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NCT00404248 · ClinicalTrials.gov registry record · Phase 1
Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma
A Phase 1 study of Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 9
- Study locations
NCT00404248: Completed Phase 1 study of Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00404248 is a Phase 1 study of Brain and Central Nervous System Tumors that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 35 participants, below the 183-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (81% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00404248, a Phase 1 study of Brain and Central Nervous System Tumors, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 9
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid (EM-1421), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of EM-1421 and to see how well it works in treating patients with recurrent high-grade glioma.
Primary Outcome
Using the PEG formulation pts both with and without enzyme inducing antiseizure drugs (EIASD) were treated at Doses 750, 1100, 1700, 2200 mg/day for five days = 28pts Using the PEG free formulation pts with and without EIASD) were treated at 1700 and 2200 mg/day X 5 days = 8pgs
Conditions Studied
Interventions
- OTHER pharmacological study
- DRUG terameprocol
Study Locations (9)
Alabama
- UAB Comprehensive Cancer Center - Birmingham
Florida
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida - Tampa
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Josephine Ford Cancer Center at Henry Ford Hospital - Detroit
North Carolina
- Wake Forest University Comprehensive Cancer Center - Winston-Salem
Ohio
- Cleveland Clinic Taussig Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT00404248 record still lists
NCT00404248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 183-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 2 interventions - of which pharmacological study is the first listed.
NCT00404248 lists 9 locations in 9 states (Alabama, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT00404248 about?
NCT00404248 is a clinical study titled "Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma". RATIONALE: Drugs used in chemotherapy, such as tetra-O-methyl nordihydroguaiaretic acid (EM-1421), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of EM...
What is the current status of trial NCT00404248?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2007-01. Estimated completion is 2012-02.
What conditions does trial NCT00404248 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.
What interventions are being tested in trial NCT00404248?
The interventions under investigation include: pharmacological study (OTHER), terameprocol (DRUG).
Who is sponsoring clinical trial NCT00404248?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00404248 being conducted?
This trial has 9 study locations across Alabama, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00404248's enrollment target sits among peer trials
35 29th of 45 higher than 17 of 45 other Brain and Central Nervous System Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain and Central Nervous System Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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