RECRUITING

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Description

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

Conditions

Lymphocytes
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Related Conditions:

Lymphocytes

Study Overview

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Study Details

Study overview

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

Tumor Infiltrating Lymphocytes in Pediatric Malignant Solid Tumors: A Prospective Biobanking Study and Phase I Clinical Trial

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Condition
Lymphocytes
Intervention / Treatment

-

Contacts and Locations

Saint Petersburg

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with active systemic infections requiring intravenous antibiotics
  • * Patients testing positive for HIV titer, hepatitis B surface antigen, human T-cell leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and fluorescent treponemal antibody (FTA) are excluded. Patients with hepatitis C antibody must have a negative (undetectable) viral load by polymerase chain reaction (PCR).
  • * Patients who are pregnant or nursing.
  • * Sexually active patients of reproductive potential are eligible if they have agreed to use an effective contraceptive method from the time of informed consent through the duration and for 1 month following completion of protocol treatment. The definition of an effective contraceptive method will be at the discretion of the institutional investigator.
  • * Patients needing chronic immunosuppressive systemic steroids are excluded. Any supraphysiologic doses of steroids should be discontinued by the time of enrollment.
  • * Patients with autoimmune diseases that require immunosuppressive medications.
  • * Patients with central nervous system metastases, currently active or in the past.
  • * Patients with history of prior solid organ transplant.
  • * Inability to comprehend and give informed consent.
  • * Patients receiving concomitant anti-cancer therapies or investigational therapies.

Ages Eligible for Study

1 Year to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lee Moffitt Cancer Center and Research Institute,

Jonathan Metts, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

2027-12-01