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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: Completed Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific and Brain and Central Nervous System Tumors, sponsored by University of California, Davis.

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. According to ClinicalTrials.gov, the official US trial registry.

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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)

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

FieldValue
Enrollment Target 30 participants
Start Date 2002-12
Est. Completion 2006-11
Phase Phase 1
University of California, Davis

657 total trials

What the finished NCT00389584 record still lists

NCT00389584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Similar trials for Unspecified Adult Solid Tumor, Protocol Specific

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 NCT00389584's enrollment target sits among peer trials

30 52nd of 83 higher than 30 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific 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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Source: ClinicalTrials.gov NCT00389584, the US trial registry maintained by the National Library of Medicine. NCT00389584 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.