rhIL-15 + Cancer Drugs for Neuroblastoma

Overseen By Hong Ha Rosa Nguyen, M.D.

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 drugs

Disqualifiers: HIV, HBV, HCV, uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Neuroblastoma is a type of cancer that causes tumors in nerves. It affects mainly infants and toddlers, and it causes about 15 percent of cancer-related deaths in children. Objective: To test a new drug (rhIL-15), combined with 3 standard cancer drugs, in people with neuroblastoma. Eligibility: People aged 3 to 35 years with neuroblastoma that did not respond or returned after standard treatment. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of their heart and lungs. They will have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle. Participants will be treated in 21-day cycles. They may have up to 4 treatment cycles. rhIL-15 is given through a needle into a vein over 5 to 7 days during the first week of each cycle. Participants will stay in the hospital while they are receiving the rhIL-15. Starting in the second week of the second cycle, participants will receive other drugs for treating cancer. They will have no study treatments during the third week of each cycle. Participants will visit the clinic at least 2 times a week throughout all 4 treatment cycles. They will have a physical exam and blood tests during these visits. Imaging scans, bone marrow biopsy, and other tests will be repeated at the end of cycles 2 and 4. Participants will have a follow-up visit 6 months after treatment ends. This visit will include a physical exam with blood and urine tests.

Research Team

Hong Ha Rosa Nguyen, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for young individuals aged 3 to 35 with neuroblastoma that has either not responded to standard treatment or has come back. They must be able to undergo various tests, including blood and urine tests, imaging scans, heart and lung exams, and a bone marrow biopsy.

Inclusion Criteria

My cancer returned or didn't respond after initial and one more treatment.

My cancer is confirmed as neuroblastoma through lab tests.

Participants must have evaluable disease according to the International Neuroblastoma Response Criteria (INRC)

Exclusion Criteria

Positive serum or urine beta-HCG pregnancy test performed at screening

I have an active HIV infection.

Current/active HBV/HCV infection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive rhIL-15, dinutuximab, irinotecan, and temozolomide in 21-day cycles, with up to 4 cycles

12 weeks

At least 2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

Treatment Details

Interventions

• Dinutuximab
• Irinotecan Hydrochloride
• rhIL-15
• Temozolomide

Trial Overview The study is testing a new drug called rhIL-15 in combination with three standard cancer drugs: Dinutuximab, Temozolomide, and Irinotecan Hydrochloride. Participants will receive treatments in cycles of 21 days up to four times, with hospital stays required during the first week of each cycle.

Participant Groups

Group I: Arm 1 Experimental Treatment 4 Interventions

Participants will receive dinutuximab at a dose of 17.5 mg/m2/day x 4 days, in combination with escalating doses of rhIL-15 and fixed dose irinotecan and temozolomide.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+