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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, rhIL-15 (a type of immunotherapy), alongside three standard cancer drugs, to determine if this combination can treat neuroblastoma, a nerve cancer primarily affecting young children. The goal is to assess whether this new treatment mix is safe and effective for those whose cancer has not responded to standard treatments or has recurred. Suitable candidates have neuroblastoma that did not respond to at least four rounds of chemotherapy and one salvage treatment, with no other treatment options available. Participants will undergo four treatment cycles, receiving rhIL-15 through an IV, with additional cancer drugs starting in the second cycle. Regular check-ups, including scans and blood tests, will monitor their progress. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken drugs that strongly affect the enzyme CYP3A4 within 7 days before enrolling.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dinutuximab, one of the drugs used in the trial, is effective and safe for treating high-risk neuroblastoma. In one study, 66% of children who received a combination treatment with dinutuximab did not experience tumor growth or recurrence. Another study found that dinutuximab was generally well-tolerated, with patients having an average survival time of 27.9 months for those with difficult-to-treat neuroblastoma.

Regarding rhIL-15, this trial is in its early stages, so researchers are primarily focused on assessing its safety and determining the appropriate dose. As a result, there may not be extensive information yet about its safety. However, the continuation of the trial suggests that earlier tests indicated potential safety. Participants in this trial will be closely monitored to ensure their safety while receiving the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of rhIL-15 and dinutuximab for neuroblastoma because it brings a fresh approach to tackling this aggressive cancer. Unlike standard treatments like chemotherapy, which target rapidly dividing cells, rhIL-15 boosts the immune system, enhancing the body's natural ability to fight cancer cells. Dinutuximab, an antibody, specifically targets a protein on neuroblastoma cells, helping the immune system to identify and destroy them. This combination aims to increase effectiveness and reduce the typical side effects seen with traditional therapies.

What evidence suggests that this trial's treatments could be effective for neuroblastoma?

Research has shown that combining rhIL-15 with dinutuximab, irinotecan, and temozolomide may help treat neuroblastoma, a type of cancer. In earlier studies, dinutuximab with similar drugs achieved an overall response rate of 41.5%, meaning nearly half of the patients experienced tumor shrinkage or improvement. This combination boosts the immune system to fight cancer cells more effectively. RhIL-15 is believed to enhance the immune response, potentially improving the efficacy of dinutuximab. This trial will administer the combination to participants to evaluate its effectiveness in treating neuroblastoma that hasn't responded to standard treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

Hong Ha Rosa Nguyen, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.

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

My cancer is confirmed as neuroblastoma through lab tests.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06995872

NCT06995872 | Phase I Trial of rhIL-15 Plus Dinutuximab ... 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 ...

2. ccr.cancer.gov ccr.cancer.gov/news/article/phase-1-clinical-trial-of-rhil-15-plus-standard-treatment-for-children-and-young-adults-with-relapsed-refractory-neuroblastoma

Phase 1 clinical trial of rhIL-15 plus standard treatment for ... Phase 1 clinical trial of rhIL-15 plus standard treatment for children and young adults with relapsed/refractory neuroblastoma.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527563/

Treatment of High-Risk Neuroblastoma with Dinutuximab ... The combined response rates of the initial and expanded cohorts demonstrated that the overall response rate of PR or better was 41.5% [4]. The ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12307510/

Efficacy and Safety of Anti-GD2 Immunotherapy with ... Best response rates with dinutuximab beta were 28.6–54.8%. All studies reported overall survival (OS), but follow-up times varied. Where reported, 3-year OS ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-00904

RhIL-15 with Dinutuximab, Irinotecan and Temozolomide ... It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Giving rhIL-15 with dinutuximab, irinotecan and temozolomide ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12471212/

Dinutuximab Beta for the Treatment of High-Risk Neuroblastoma This retrospective study demonstrates that dinutuximab beta is an effective and safe treatment for high-risk neuroblastoma, achieving a 54.1% ...

7. cancer.gov cancer.gov/news-events/cancer-currents-blog/2022/study-confirms-dinutiximab-high-risk-neuroblastoma

Kids with High-Risk Neuroblastoma Benefit from Dinutuximab Similarly, 66% of children treated with the dinutuximab combination remained free of tumor growth or recurrence, compared with 46% who were ...

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1082771/full

Dinutuximab beta combined with chemotherapy in patients ... In a meta-analysis of data from Phase II trials, median overall survival (OS) was 27.9 months for patients with refractory neuroblastoma and ...

9. clin.larvol.com clin.larvol.com/trial-detail/NCT06995872

Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan ... Outcome Measure, Measure Description, Time Frame. Assess the safety and determine the MTD of rhIL-15 combined with dinutuximab/temozolomide/irinotecan ...