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Peripheral Blood Stem Cell Transplant (PBSCT) in Children With High Risk or Recurrent Solid Tumors

NCT00966498 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2013-12-11

No results posted yet for this study

Summary

Before the transplant, the patient will have a pre-transplant evaluation. This will help find out whether there are health problems that will prevent the transplant. It also provides "baseline" tests that will be used later to see whether or not organs have gotten better or worse after the transplant. Prior to the stem cell collection, the patient will get chemotherapy to help try to put him/her in remission and to push more stem cells into the peripheral blood (mobilization). The study doctor will decide which chemotherapy will be used for this part of the study. Once mobilization is completed, the peripheral blood stem cell collection (apheresis) will be done in the clinic. The apheresis machine will draw blood out of the central line. The blood then passes through the apheresis machine and the stem cells are separated out. The remaining blood is sent back through the central line. If the investigators are unable to collect enough peripheral blood stem cells, a bone marrow harvest may be necessary to collect more stem cells.

The patient will then be admitted to the hospital for the first transplant. He/she will get Thiotepa and Cyclophosphamide. Then the patient will be given back the cells that were collected. The cells are given in the same manner as a blood transfusion. The patient will be kept in the hospital until he/she is stable and blood counts are increasing. Approximately 6 to 8 weeks after Day 0 of the 1st transplant, the patient will be admitted for the second transplant. At this time, he/she will get Busulfan and Melphalan and then the collected cells will be given back. The patient will be kept in the hospital until he/she is stable and blood counts are increasing. Frequent clinic follow-up is required.

This study is open to patients who are less then 21 years of age with refractory or relapsed high-risk, solid tumors, excluding neuroblastoma (there is a cooperative group trial for these patients). Patients will be identified by the Transplant team and eligibility will be verified by a member of the clinical research team. Patients will be cared for by members of the Transplant team and various other subspecialty physicians.

Conditions

  • High Risk Solid Tumors
  • Recurrent Solid Tumors

Interventions

PROCEDURE

Peripheral Blood Stem Cell Transplant

Peripheral Blood Stem Cell Transplant

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Kuang-Yueh Chiang, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00966498 on ClinicalTrials.gov