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NCT00486603 · ClinicalTrials.gov registry record · Phase 1
Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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
- 92
- Enrollment target
- 9
- Study locations
NCT00486603: Completed Phase 1 study of Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00486603 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 92 participants, below the 182-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (49% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00486603, 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
- 92 participants
- Enrollment target
- 9
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving hydroxychloroquine together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with radiation therapy and temozolomide and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.
Primary Outcome
Number of participants who tolerated doses of HCQ without dose limiting toxicity. The highest dose at which participants did not experience dose limiting toxicity was determined as the MTD.
Conditions Studied
Interventions
- RADIATION Radiation
- DRUG temozolomide
- OTHER pharmacological study
- DRUG hydroxychloroquine
Study Locations (9)
Alabama
- University of Alabama at Birmingham 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
- Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2007-10-29 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT00486603 record still lists
NCT00486603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 182-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (49% lower).
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 Radiation is the first listed.
NCT00486603 lists 9 locations in 9 states (Alabama, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT00486603 about?
NCT00486603 is a clinical study titled "Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme". RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving hydroxychloroquine togeth...
What is the current status of trial NCT00486603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2007-10-29. Estimated completion is 2014-01.
What conditions does trial NCT00486603 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.
What interventions are being tested in trial NCT00486603?
The interventions under investigation include: Radiation (RADIATION), temozolomide (DRUG), pharmacological study (OTHER), hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT00486603?
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 NCT00486603 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
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 NCT00486603's enrollment target sits among peer trials
92 17th of 45 higher than 29 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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