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NCT00048386 · ClinicalTrials.gov registry record · Phase 1

Neuroblastoma Vaccine for Treatment of High-Risk Neuroblastoma After Chemotherapy

A Phase 1 study of Neuroblastoma, sponsored by Malcolm Brenner.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT00048386 is a Phase 1 study of Neuroblastoma that has completed, run by Malcolm Brenner. The registered enrollment target is 13 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00048386, a Phase 1 study of Neuroblastoma, has completed, sponsored by Malcolm Brenner.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target
1
Study location

Study Summary

PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in first or subsequent partial response or better, or with microscopic residual bone marrow disease, who demonstrate an immunological anti-tumor response at any time during, and for up to 12 months from initiation of, treatment with subcutaneous injections of autologous neuroblastoma cells, genetically modified by adenoviral vectors to secrete interleukin-2 (IL-2) (autologous neuroblastoma vaccine) SECONDARY OBJECTIVES 1. To determine the toxicity of the autologous neuroblastoma vaccine given according to this schedule 2. To obtain preliminary data on the effect of vaccine administration on progression-free survival from high-risk neuroblastoma

Conditions Studied

Interventions

  • BIOLOGICAL autologous neuroblastoma vaccine

Study Locations (1)

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 1999-11
Est. Completion 2009-10
Phase Phase 1

Sponsor

Malcolm Brenner

1 total trials

What the Registry Record Tells You About NCT00048386

The ClinicalTrials.gov registry entry for NCT00048386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (95% lower). The listed sponsor is Malcolm Brenner, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which autologous neuroblastoma vaccine is the first listed.

NCT00048386 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00048386 about?

NCT00048386 is a clinical study titled "Neuroblastoma Vaccine for Treatment of High-Risk Neuroblastoma After Chemotherapy". PRIMARY OBJECTIVE To determine the percentage of patients with high risk neuroblastoma in first or subsequent partial response or better, or with microscopic residual bone marrow disease, who demonstrate an immunological anti-tumor response at any time during, and for up to 12 months from initiation...

What is the current status of trial NCT00048386?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 1999-11. Estimated completion is 2009-10.

What conditions does trial NCT00048386 study?

This clinical trial studies the following conditions: Neuroblastoma.

What interventions are being tested in trial NCT00048386?

The interventions under investigation include: autologous neuroblastoma vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00048386?

This trial is sponsored by Malcolm Brenner, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00048386 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.