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NCT00503880 · ClinicalTrials.gov registry record · Phase 1
Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes
A Phase 1 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00503880: Clinical Trial Phase 1 study, sponsored by University of Nebraska.
NCT00503880 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00503880, a Phase 1 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or in peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving clofarabine and cytarabine together with G-CSF may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and G-CSF in treating patients with myelodysplastic syndromes.
Primary Outcome
Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 2 out of 6 patients experience dose limiting toxicities or the highest dose cohort, if 2 limiting toxicities are not observed at any dose cohort. These will be presented as actual rates. Dose limiting toxicity (DLT) will be defined according to oncology standards based on NCI CTC version 2 grading criteria (DLT = \> grade 3 non-hematological toxicity or any \> 4 hematological toxicity that persists for more than 4 weeks an
Interventions
- GENETIC microarray analysis
- PROCEDURE biopsy
- DRUG clofarabine
- BIOLOGICAL filgrastim
- DRUG cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2007-05-07 |
| Est. Completion | 2009-10-13 |
| Phase | Phase 1 |
Why NCT00503880 stopped before completion
NCT00503880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which microarray analysis is the first listed.
NCT00503880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00503880 about?
NCT00503880 is a clinical study titled "Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes". RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow...
What is the current status of trial NCT00503880?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2007-05-07. Estimated completion is 2009-10-13.
What interventions are being tested in trial NCT00503880?
The interventions under investigation include: microarray analysis (GENETIC), biopsy (PROCEDURE), clofarabine (DRUG), filgrastim (BIOLOGICAL), cytarabine (DRUG).
Who is sponsoring clinical trial NCT00503880?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00503880's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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