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NCT00005835 · ClinicalTrials.gov registry record · Phase 1

N99-02: Melphalan and Buthionine Sulfoximine

A Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target
9
Study locations

NCT00005835: Completed Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

NCT00005835 is a Phase 1 study of Neuroblastoma that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 31 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (87% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005835, a Phase 1 study of Neuroblastoma, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target
9
Study locations

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

What the finished NCT00005835 record still lists

NCT00005835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (87% lower).

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.

NCT00005835 lists 9 locations in 8 states (California, Illinois, Massachusetts).

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.

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).

Who is sponsoring clinical trial NCT00005835?

This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Neuroblastoma

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 NCT00005835's enrollment target sits among peer trials

31 59th of 94 higher than 36 of 94 other Neuroblastoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neuroblastoma 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 NCT00005835, the US trial registry maintained by the National Library of Medicine. NCT00005835 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.