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NCT00070200 · ClinicalTrials.gov registry record · Phase 1

Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma

A Phase 1 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT00070200: Completed Phase 1 study, sponsored by Children's Oncology Group.

NCT00070200 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00070200, a Phase 1 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of induction chemotherapy using cyclophosphamide and topotecan in treating patients who are undergoing surgery and autologous stem cell transplantation followed by radiation therapy for newly diagnosed or progressive neuroblastoma.

Primary Outcome

Given that the documented delivered dose intensity of chemotherapy in current induction regimens is 75-85% of the intended dose intensity,5,78 we shall consider an individual patient as a "success" in terms of feasibility if the patient is able to receive 75% or more of the intended chemotherapy doses of known active agents.

Interventions

  • DRUG cisplatin
  • DRUG cyclophosphamide
  • DRUG etoposide
  • BIOLOGICAL filgrastim
  • DRUG doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2004-03
Est. Completion 2013-12
Phase Phase 1
Children's Oncology Group

342 total trials

What the finished NCT00070200 record still lists

NCT00070200 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.

NCT00070200 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00070200 about?

NCT00070200 is a clinical study titled "Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma". RATIONALE: Drugs used in chemotherapy, such as topotecan and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill m...

What is the current status of trial NCT00070200?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2004-03. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00070200?

The interventions under investigation include: cisplatin (DRUG), cyclophosphamide (DRUG), etoposide (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00070200?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00070200's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00070200, the US trial registry maintained by the National Library of Medicine. NCT00070200 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.