TIL Therapy for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByJonathan Metts, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of 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 is for children and young adults aged 1 to 21 with high-risk solid tumors outside the brain. They must have recovered from previous cancer treatments, meet organ function requirements, and not be pregnant or nursing. Participants need a Karnofsky/Lansky score of at least 60%, no active infections requiring IV antibiotics, no CNS metastases history, and cannot be on other cancer therapies.

Inclusion Criteria

You have verified the availability of an acceptable TIL cellular product.

This is a prospective biobanking research study.

I am scheduled for an open surgical biopsy or resection for my tumor.

+29 more

Exclusion Criteria

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.

I am not on long-term steroids for immune suppression.

I have or had brain metastases.

+9 more

Participant Groups

The study has two parts: first to see if it's possible to make TIL (Tumor-Infiltrating Lymphocyte) products from pediatric tumors; second to test the safety of TIL therapy combined with lymphodepleting chemo drugs Fludarabine and Cyclophosphamide followed by Interleukin-2 in these patients.

1Treatment groups

Experimental Treatment

Group I: TIL TherapyExperimental Treatment1 Intervention

TIL therapy with lymphodepleting chemotherapy and Interleukin 2