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COMPLETED Phase 1

N99-02: Melphalan and Buthionine Sulfoximine

NCT00005835 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine followed by bone marrow or peripheral stem cell transplantation in treating children who have resistant or recurrent neuroblastoma.

Conditions Studied

Interventions

  • DRUG melphalan
  • DRUG buthionine sulfoximine
  • PROCEDURE Peripheral blood stem cell infusion
  • OTHER Filgrastim

Study Locations (9)

California

  • Childrens Hospital Los Angeles — Los Angeles
  • UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco

Illinois

  • University of Chicago Comer Children's Hospital — Chicago

Massachusetts

  • Childrens Hospital Boston, Dana-Farber Cancer Institute. — Boston

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

Texas

  • Cook Children's Medical Center - Fort Worth — Fort Worth

Washington

  • Children's Hospital and Regional Medical Center - Seattle — Seattle

Ontario

  • Hospital for Sick Children — Toronto

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2001-08
Est. Completion 2016-04
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00005835

The ClinicalTrials.gov registry entry for NCT00005835 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 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 39 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 Neuroblastoma appearing as the primary indexed condition, and to 4 interventions — of which melphalan 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: NCT00005835 reports 9 study locations spanning 8 distinct geographic areas — top geographies include California, Illinois, 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 NCT00005835 about?

NCT00005835 is a clinical study titled "N99-02: Melphalan and Buthionine Sulfoximine". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE:...

What is the current status of trial NCT00005835?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2001-08. Estimated completion is 2016-04.

What conditions does trial NCT00005835 study?

This clinical trial studies the following conditions: Neuroblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00005835?

The interventions under investigation include: melphalan (DRUG), buthionine sulfoximine (DRUG), Peripheral blood stem cell infusion (PROCEDURE), Filgrastim (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00005835?

This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00005835 being conducted?

This trial has 9 study locations across California, Illinois, Massachusetts, Ohio, Pennsylvania. 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