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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. 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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00043979
The ClinicalTrials.gov registry entry for NCT00043979 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00043979 reports 0 study locations.
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.
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