Protocol

RADIANT: A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children with Relapsed or Refractory Solid Tumors or Lymphomas

Diseases

Stem Cell / Bone Marrow Transplant : Relapsed or refractory solid tumors or lymphomas

Description

This is a phase I study designed to determine the possibility of a new treatment using stem cell transplantation. This is a two-step process. It starts with giving chemotherapy medications to damage or kill the patient’s bone marrow. By damaging or killing the bone marrow, room is made within the bones-called the “bone marrow space.” The patient then gets stem cells from bone marrow of another person called the “donor.” Donor stem cells are needed in order to restore and “rebuild” the patient’s bone marrow that has been damaged from the chemotherapy and to help build healthy immune and blood cell forming systems.

Additionally, we intend to study blood cell recovery as well as infection rates and other complications. We expect that 12 transplant recipients will participate in the study over the next 3 years.

Objectives

• To learn about the safety and use of this study transplant procedure on participants with difficult to treat solid tumors and lymphomas.
• To learn more about how the immune system (infection fighting system) develops and works for participants who receive this study transplant procedure.
• To learn more about how the different blood cell types of study participants act after receiving this study transplant procedure.
• To learn more about the infections and complications of participants who receive this study transplant procedure.
• To learn more about the overall survival rate and the effects of this study treatment on participants who receive this study transplant procedure.

Eligibility

Transplant recipient

• At least 2 years of age and less than or equal to 21 years of age
• Patients with histologically confirmed solid tumor or lymphoma at original diagnosis: Ewing sarcoma family of tumors (ESFT), gastrointestinal tumors, germ cell tumors, hepatic tumors, lymphoma, kidney tumors, melanoma, neuroblastoma, soft tissue sarcoma.
• Adequate heart and kidney and liver function
• At least two weeks since receipt of any therapy (biological, chemotherapy, and or radiation therapy).

Eligibility

Transplant donor

• At least 18 years of age
• Human immunodeficiency virus (HIV) negative
• Partially HLA matched family member

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
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: 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.