Health TrialsbyHealthPanel

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

ConditionLymphocytes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-21
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be ≥1 year to ≤ 21 years of age at time of enrollment to Part One.

High-risk neuroblastoma

Metastatic Ewing sarcoma

Metastatic osteosarcoma

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2

    Biological/Vaccine

    Lymphodepleting Chemotherapy with Fludarabine/Cyclophosphamide followed by TIL and Post-TIL Interleukin-2 (IL-2)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TIL TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of TIL therapy in Pediatric Solid Tumors

The regimen will be declared safe if \<33% of patients (0 or 1 out of maximum 6 patients on the safety phase) experience a dose-limiting toxicity (DLT).

Time frame
3 years

Secondary outcomes

1

Feasibility of Generating TIL Product from Pediatric Solid Tumors

The TIL acquisition/production strategies will be considered feasible if 50% or more of all tumors collected on the prospective biobanking study generate a primary TIL culture that is satisfactory for rapid expansion for use on the Phase I trial.

Time frame
3 years
2

Toxicity of TIL Therapy in Pediatric Solid Tumors

Toxicities of all grades related to therapy and all Grade 3 and higher toxicities will be collected.

Time frame
3 years
3

Disease Response to TIL Therapy

For recurrent patients with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used. For all patients, event-free survival (EFS) will be reported.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Swim Across America

Collaborator

Benjamin Gilkey Fund

Collaborator

Cannonball Kids' Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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