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NCT00365222 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00365222 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 1 participants.
The verdict
NCT00365222, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days. Procedures prior to initial study treatment (\<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast. The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast. Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.
Interventions
- DRUG Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00365222
The ClinicalTrials.gov registry entry for NCT00365222 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Temozolomide is the first listed.
NCT00365222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00365222 about?
NCT00365222 is a clinical study titled "Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma". A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomi...
What is the current status of trial NCT00365222?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2006-07. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00365222?
The interventions under investigation include: Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00365222?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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