Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors

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Research

Protocol

NKEXP: Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors

Diseases

Leukemias / Lymphomas : Refractory or relapsed leukemia (AML, T-ALL, CML, JMML), T-cell lymphoma, myelodysplastic syndrome, Ewing sarcoma (ESFT), rhabdomyosarcoma (RMS)

Description

This research study will evaluate a new treatment of infusing donor natural killer (NK) blood cells in patients with relapsed or refractory leukemia, lymphoma or solid tumors. NK cells are a type of lymphocyte/white blood cell that has been found to attack viruses and “kill” some cancer cells. This study will review the safety of infusing (giving by vein) NK cells obtained from a family member in children and young adults with cancer. Before these NK cells are infused, they will be “expanded” in a laboratory at St. Jude Children’s Research Hospital. Expanding the donor cells means the cells will be stimulated to increase in number and ability to kill cancer cells.

This research study involves two parts or “phases” as follows: Phase I: where a blood test called “expansion evaluation” that will determine if a family member is able to be an NK cell donor and Phase II: which includes NK cell collection, expansion and processing. If a donor is able to donate their NK cells and if the NK cells expand, the recipient patient will be infused with the donor NK cells. The NK collection and expansion process will take approximately 1 month. This study requires the participant and his/her caregiver to stay in or near Memphis for at least 90 days after the NK cell infusion for bone marrow testing on or about 1, 2 and 3 months after the study infusion. A final test will be done 1 year after NK cell infusion time point. The scheduled tests or evaluations are always subject to change (be done more or less often than noted) due to the participant’s medical condition.

Objectives

To determine the maximum tolerated dose of expanded NK cells in research participants with relapsed or refractory hematologic malignancies and sarcomas
To learn how these expanded NK cells work and how long they survive in participants who receive this study intervention.
To gain knowledge about the effect of infusing expanded donor NK cells on the disease of participants who receive this study infusion.

Eligibility for Recipients

Age: less than or equal to 18 years of age. May be greater than 18 years of age if currently a St. Jude patient.
Patients with relapsed or refractory AML, T-ALL/T-LL, CML, JMML or MDS, ESFCT or RMS who are not eligible for SCT and have persistent disease after remission induction(s) therapy as evidenced by bone marrow morphology, cytogenetics, flow cytometry, molecular pathology, and/or restaging scans.
At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy.
Heart, lungs, kidney, liver and overall performance status must be within normal limits as defined by protocol.
No known allergy to murine products or HAMA testing results within normal limits.
Has not received an allogeneic hematopoietic stem cell transplant.
Does not have a current pleural or pericardial effusion.
Has a suitable adult family member donor available for NK cell donation.

Eligibility for Donors

Family member with a greater than or equal to 3 of 6 HLA match to recipient.
At least 18 years of age.
HIV negative (test result within 60 days prior to Phase I enrollment).
Not pregnant and/or lactating

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

David Shook, MD
St. Jude Children’s Research Hospital
332 North Lauderdale
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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