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NCT00305864 · ClinicalTrials.gov registry record · Phase 1
Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
NCT00305864: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00305864 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 118 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305864, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Motexafin gadolinium may help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with temozolomide and radition therapy may kill more tumor cells.
Primary Outcome
Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was co
Interventions
- DRUG Temozolomide
- RADIATION 3-Dimensional Conformal Radiation Therapy
- DRUG Motexafin Gadolinium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2006-02-09 |
| Est. Completion | 2011-03-15 |
| Phase | Phase 1 |
What the finished NCT00305864 record still lists
NCT00305864 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT00305864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00305864 about?
NCT00305864 is a clinical study titled "Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma". This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. Drugs used in chemothera...
What is the current status of trial NCT00305864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2006-02-09. Estimated completion is 2011-03-15.
What interventions are being tested in trial NCT00305864?
The interventions under investigation include: Temozolomide (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION), Motexafin Gadolinium (DRUG).
Who is sponsoring clinical trial NCT00305864?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00305864's enrollment target sits among peer trials
118 499th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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