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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 is a Phase 1 study that was terminated before completion, run by Eastern Cooperative Oncology Group. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00052884
The ClinicalTrials.gov registry entry for NCT00052884 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Cooperative Oncology Group, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which melphalan is the first listed.
NCT00052884 reports 0 study locations.
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.
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