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NCT00052884 · ClinicalTrials.gov registry record · Phase 1
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
A Phase 1 study, sponsored by Eastern Cooperative Oncology Group.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00052884: Clinical Trial Phase 1 study, sponsored by Eastern Cooperative Oncology Group.
NCT00052884 is a Phase 1 study that was terminated before completion, run by Eastern Cooperative Oncology Group. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00052884, a Phase 1 study, was terminated before completion, sponsored by Eastern Cooperative Oncology Group.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.
Primary Outcome
The maximum tolerated dose is the highest dose level at which fewer than 1 of 3 or 2 of 6 patients experience dose-limiting toxicity, defined as any grade 3 or higher toxicity of any of the following: renal failure, alkaline phosphatase elevation, GI bleeding, and cardiac rhythm disturbances, assessed using NCI Common Toxicity Criteria, version 2.0.
Interventions
- DRUG melphalan
- PROCEDURE peripheral blood stem cell transplantation
- BIOLOGICAL filgrastim
- DRUG amifostine trihydrate
- PROCEDURE bone marrow ablation with stem cell support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2004-01-22 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
Why NCT00052884 stopped before completion
NCT00052884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which melphalan is the first listed.
NCT00052884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00052884 about?
NCT00052884 is a clinical study titled "Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to...
What is the current status of trial NCT00052884?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2004-01-22. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00052884?
The interventions under investigation include: melphalan (DRUG), peripheral blood stem cell transplantation (PROCEDURE), filgrastim (BIOLOGICAL), amifostine trihydrate (DRUG), bone marrow ablation with stem cell support (PROCEDURE).
Who is sponsoring clinical trial NCT00052884?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00052884's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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