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COMPLETED Phase 1

Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors

NCT00389584 · View on ClinicalTrials.gov ↗

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

Sponsor

University of California, Davis

653 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 653 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00389584 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00389584?

This trial is sponsored by University of California, Davis, which has 653 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial