View Clinical Trial (Medical Research Study)
Immune Reconstitution in Oncology Patients Following Autologous Stem Cell Transplant
| City: |
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Memphis |
| State: |
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Tennessee |
| Zip Code: |
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38103 |
| Conditions: |
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Solid Tumor - Brain Tumor - Lymphoma |
| Purpose: |
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Autologous stem cell rescue is an established therapy in high risk neuroblastoma and
relapsed Hodgkin's lymphoma and an experimental therapy in some other solid and brain tumors
to facilitate the use of very intense chemotherapy beyond bone marrow tolerance. It is
usually tolerated with acceptable toxicity and graft failure is practically not existent.
But whereas immune reconstitution in allogeneic hematopoietic stem cell transplantation
(HSCT) setting is widely studied, the investigators have no comprehensive data available in
the autologous setting regarding recovery of the innate and adaptive immune system. However,
observations in patients with autoimmune disease undergoing autologous HSCT suggest not an
exact recovery of the patient's pre-transplant immune system but some re-education during
reconstitution of immune function.
Also, recent developments of cancer-directed immunotherapy with monoclonal antibodies and
immunocytokines rely on activity of the patient's own immune system via complement-mediated
or antibody-dependent cellular cytotoxicity. These novel therapies are given either with or
shortly after conventional chemotherapy. To find the optimal time point for administration
of immunotherapy, it is important to know how and when immune effector cells recover after
conventional myelosuppressive and/or immunosuppressive chemotherapy which are used in
Induction regimens.
Researchers at St. Jude Children's Research Hospital want to study the research
participant's immune profile once prior and at multiple set time points after autologous
stem cell infusion during the recovery process. In a subset of participants the
investigators want to study the recovery of lymphocyte subsets and function after one course
of conventional chemotherapy preceding the high dose chemotherapy and autologous stem cell
transplant. That way the investigators hope to learn about the pace and order of recovery
and the functional capacity of different compartments of the immune system during
reconstitution.
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| Study Summary: |
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Primary Objective:
- To describe the immune reconstitution of T cell-, B cell- and natural killer (NK) cell-
compartment in patients undergoing autologous stem cell transplant as part of their
treatment for a malignancy.
The design for this study will be a prospective, longitudinal observational study. Immune
reconstitution will be measured in the course of autologous stem cell transplant using
serial blood samples analyzed for cell counts, immune cell phenotyping (demonstrating the
expression of specific receptors on the cell surface) and functional lymphocyte assays.
These blood samples will be obtained once prior and at defined time points after stem cell
infusion either while the research participant is hospitalized or during the scheduled
clinic visit.
Immune recovery from conventional chemotherapy will be measured using serial blood samples
analyzed for cell counts, immune cell phenotyping, and NK cell functional assays. These
blood samples will be obtained once prior and at defined time points after completion of
courses #1 and #4 of Induction chemotherapy while the research participant is hospitalized
or during the scheduled clinic visit.
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| Criteria: |
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Inclusion Criteria:
- Patients with solid tumors, brain tumors or lymphoma regardless of previously
received cancer related therapies who are enrolled on a study protocol or treatment
plan that includes or will likely include autologous stem cell transplant.
- Patient age >0 to 21 years
Exclusion Criteria:
- Patient receiving an autologous transplant for a disease other than listed above.
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| NCT ID: |
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NCT01540175 |
| Primary Contact: |
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Principal Investigator
Susanne Wendt, MD
St. Jude Children's Research Hospital
Susanne Wendt, MD
Phone: 866-278-5833
Email: info@stjude.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Memphis, Tennessee 38103
United States
Susanne Wendt, MD
Phone: 866-278-5833
Email: info@stjude.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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