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COMPLETED Phase 1

Gene Therapy in Treating Patients With Recurrent Malignant Gliomas

NCT00004041 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Inserting the gene for adenovirus p53 into a person's tumor may improve the body's ability to fight cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent malignant gliomas.

Interventions

  • PROCEDURE conventional surgery
  • BIOLOGICAL Ad5CMV-p53 gene

Study Locations (8)

Texas

  • Simmons Cancer Center - Dallas — Dallas
  • University of Texas - MD Anderson Cancer Center — Houston
  • University of Texas Health Science Center at San Antonio — San Antonio

California

  • UCSF Cancer Center and Cancer Research Institute — San Francisco

Massachusetts

  • Dana-Farber Cancer Institute — Boston

Michigan

  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Pennsylvania

  • University of Pittsburgh Cancer Institute — Pittsburgh

Wisconsin

  • University of Wisconsin Comprehensive Cancer Center — Madison

Trial Details

FieldValue
Start Date 1999-02-25
Est. Completion 2003-07-01
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00004041

The ClinicalTrials.gov registry entry for NCT00004041 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. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 2 interventions — of which conventional surgery 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: NCT00004041 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, Massachusetts. 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 NCT00004041 about?

NCT00004041 is a clinical study titled "Gene Therapy in Treating Patients With Recurrent Malignant Gliomas". RATIONALE: Inserting the gene for adenovirus p53 into a person's tumor may improve the body's ability to fight cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent malignant gliomas.

What is the current status of trial NCT00004041?

This trial is currently completed. It is a Phase 1 study. The study started on 1999-02-25. Estimated completion is 2003-07-01.

What conditions does trial NCT00004041 study?

This clinical trial studies the following conditions: Brain and Central Nervous System Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00004041?

The interventions under investigation include: conventional surgery (PROCEDURE), Ad5CMV-p53 gene (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00004041?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00004041 being conducted?

This trial has 8 study locations across California, Massachusetts, Michigan, Pennsylvania, Texas. 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