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NCT00003597 · ClinicalTrials.gov registry record · Phase 1
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00003597: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT00003597 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003597, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.
Primary Outcome
To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E. myelosuppressive chemotherapy.
Interventions
- DRUG carboplatin
- BIOLOGICAL G-CSF
- DRUG etoposide
- DRUG ifosfamide
- BIOLOGICAL recombinant human thrombopoietin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 1998-11 |
| Est. Completion | 2005-09 |
| Phase | Phase 1 |
What the finished NCT00003597 record still lists
NCT00003597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which carboplatin is the first listed.
NCT00003597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003597 about?
NCT00003597 is a clinical study titled "Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system r...
What is the current status of trial NCT00003597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 1998-11. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00003597?
The interventions under investigation include: carboplatin (DRUG), G-CSF (BIOLOGICAL), etoposide (DRUG), ifosfamide (DRUG), recombinant human thrombopoietin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00003597?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003597's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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