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NCT00467051 · ClinicalTrials.gov registry record · Phase 2

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

A Phase 2 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT00467051: Completed Phase 2 study, sponsored by Children's Oncology Group.

NCT00467051 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00467051, a Phase 2 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Primary Outcome

Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.

Interventions

  • DRUG Carboplatin
  • OTHER Laboratory Biomarker Analysis
  • DRUG Paclitaxel
  • BIOLOGICAL Filgrastim
  • DRUG Ifosfamide

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-11-05
Est. Completion 2018-06-30
Phase Phase 2
Children's Oncology Group

342 total trials

What the finished NCT00467051 record still lists

NCT00467051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

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

NCT00467051 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00467051 about?

NCT00467051 is a clinical study titled "Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors". This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, eit...

What is the current status of trial NCT00467051?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2007-11-05. Estimated completion is 2018-06-30.

What interventions are being tested in trial NCT00467051?

The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Filgrastim (BIOLOGICAL), Ifosfamide (DRUG).

Who is sponsoring clinical trial NCT00467051?

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 NCT00467051's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00467051, the US trial registry maintained by the National Library of Medicine. NCT00467051 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.