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NCT00389584 · ClinicalTrials.gov registry record · Phase 1
Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors
A Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Brain and Central Nervous System Tumors, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00389584 is a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Brain and Central Nervous System Tumors that has completed, run by University of California, Davis. The registered enrollment target is 30 participants, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00389584, a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Brain and Central Nervous System Tumors, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, 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. Irinotecan may make tumor cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when given together with whole-brain radiation therapy and to see how well they work in treating patients with brain metastases from solid tumors. (The study of side effects and best dose has ended as of 4/15/05)
Conditions Studied
Interventions
- RADIATION radiation therapy
- PROCEDURE cognitive assessment
- DRUG irinotecan hydrochloride
- PROCEDURE management of therapy complications
Study Locations (1)
California
- University of California Davis Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-12 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00389584
The ClinicalTrials.gov registry entry for NCT00389584 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (94% lower). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 4 interventions - of which radiation therapy is the first listed.
NCT00389584 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00389584 about?
NCT00389584 is a clinical study titled "Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors". RATIONALE: Drugs used in chemotherapy, such as irinotecan, 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. Irinotecan may make tumor cells more sensitive to radiati...
What is the current status of trial NCT00389584?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2002-12. Estimated completion is 2006-11.
What conditions does trial NCT00389584 study?
This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific, Brain and Central Nervous System Tumors, Unspecified Childhood Solid Tumor, Protocol Specific, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Adults.
What interventions are being tested in trial NCT00389584?
The interventions under investigation include: radiation therapy (RADIATION), cognitive assessment (PROCEDURE), irinotecan hydrochloride (DRUG), management of therapy complications (PROCEDURE).
Who is sponsoring clinical trial NCT00389584?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00389584 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.