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NCT00602667 · ClinicalTrials.gov registry record · Phase 2
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
A Phase 2 study of Brain and Central Nervous System Tumors, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 293
- Enrollment target
- 6
- Study locations
NCT00602667: Active Phase 2 study of Brain and Central Nervous System Tumors, sponsored by St. Jude Children's Research Hospital.
NCT00602667 is a Phase 2 study of Brain and Central Nervous System Tumors that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 293 participants, above the 177-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (66% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602667, a Phase 2 study of Brain and Central Nervous System Tumors, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 293 participants
- Enrollment target
- 6
- Study locations
Study Summary
RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important part of the two clinical trials which resulted in the best survival results for children less than 3 years of age with medulloblastoma. Most patients treated on this trial will also receive radiation which is carefully targeted to the area of the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in fewer problems with thinking and learning than radiation to the whole brain and spinal cord. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.
Primary Outcome
Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.
Conditions Studied
Interventions
- DRUG Induction Chemotherapy
- DRUG Low-Risk Therapy
- DRUG High-Risk Therapy
- DRUG Intermediate-Risk Therapy
Study Locations (6)
California
- Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
- Rady Children's Hospital - San Diego
Minnesota
- Children's Hospitals and Clinics of Minnesota - St. Paul - Saint Paul
Tennessee
- St. Jude Children's Research Hospital - Memphis
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
Queensland
- Lady Cilento Children's Hospital, Brisbane - Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2007-12-17 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT00602667 still lists
NCT00602667 is an interventional study that assigns participants to a tested intervention. The registered 293 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (66% higher).
The record links to 1 condition, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 4 interventions - of which Induction Chemotherapy is the first listed.
NCT00602667 lists 6 locations in 5 states (California, Minnesota, Tennessee).
Frequently Asked Questions
What is clinical trial NCT00602667 about?
NCT00602667 is a clinical study titled "Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma". RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important par...
What is the current status of trial NCT00602667?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 293 participants. The study started on 2007-12-17. Estimated completion is 2026-04.
What conditions does trial NCT00602667 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.
What interventions are being tested in trial NCT00602667?
The interventions under investigation include: Induction Chemotherapy (DRUG), Low-Risk Therapy (DRUG), High-Risk Therapy (DRUG), Intermediate-Risk Therapy (DRUG).
Who is sponsoring clinical trial NCT00602667?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602667 being conducted?
This trial has 6 study locations across California, Minnesota, Tennessee, Texas, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain and Central Nervous System Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00602667's enrollment target sits among peer trials
293 7th of 45 higher than 39 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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