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NCT00043979 · ClinicalTrials.gov registry record · Phase 2
Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00043979: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00043979 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00043979, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of stem cell transplantation for treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). Stem cells are immature cells in the bone marrow and blood stream that develop into blood cells. Stem cells transplanted from a healthy donor travel to the patient's bone marrow and begin producing normal cells. In patients with certain cancers, such as leukemia and lymphoma, the donor's immune cells attack the patient's cancer cells in what is called a "graft-versus-tumor" effect, contributing to cure of the disease. This study will determine whether this treatment can be used successfully to treat patients with sarcomas. Patients between 4 and 35 years of age with a sarcoma that has spread from the primary site or cannot be removed surgically, and for whom effective treatment is not available, may be eligible for this study. Candidates must have been diagnosed by the age of 30 at the time of enrollment. They must have a matched donor (usually a sibling). Participants undergo the following procedures: Donors: Stem cells are collected from the donor. To do this, the hormone granulocyte colony stimulating factor (G-CSF) is injected under the skin for several days to move stem cells out of the bone marrow into the bloodstream. Then, the cells are collected by apheresis. In this procedure the blood is drawn through a needle placed in one arm and pumped into a machine where the stem cells are separated out and removed. The rest of the blood is returned to the donor through a needle in the other arm. Patients: For patients who do not already have a central venous catheter (plastic tube), one is placed into a major vein. This tube can stay in the body the entire treatment period for giving medications, transfusing blood, , withdrawing blood samples, and delivering the donated stem cells. Before the transplant procedure, patients receive from one to three cycles of "induction" chemotherapy, with each cycle co
Primary Outcome
Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, \>95% donor engraftment at day 100 in \>75% of patients.
Interventions
- DRUG cyclophosphamide
- DRUG doxorubicin hydrochloride
- DRUG cyclosporine
- BIOLOGICAL therapeutic allogeneic lymphocytes
- DRUG F-18 Fluorodeoxyglucose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-09-19 |
| Est. Completion | 2011-12-14 |
| Phase | Phase 2 |
What the finished NCT00043979 record still lists
NCT00043979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00043979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00043979 about?
NCT00043979 is a clinical study titled "Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas". This study will examine the safety and effectiveness of stem cell transplantation for treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). Stem cells are immature cells in the bone marrow and blood stream that develop into blood cells. Stem cells transplanted from a healthy ...
What is the current status of trial NCT00043979?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-09-19. Estimated completion is 2011-12-14.
What interventions are being tested in trial NCT00043979?
The interventions under investigation include: cyclophosphamide (DRUG), doxorubicin hydrochloride (DRUG), cyclosporine (DRUG), therapeutic allogeneic lymphocytes (BIOLOGICAL), F-18 Fluorodeoxyglucose (DRUG).
Who is sponsoring clinical trial NCT00043979?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00043979's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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