What side effects are associated with this type of intervention?

Common treatments for Neuroblastoma, particularly those involving chemotherapy and immunotherapy, can have several side effects. Chemotherapy agents like irinotecan and temozolomide may cause nausea, vomiting, diarrhea, and myelosuppression, leading to increased risk of infections and anemia. Immunotherapy agents like dinutuximab can cause pain, fever, capillary leak syndrome, and allergic reactions. Additionally, treatments targeting immune modulation, such as NK cell therapies, may lead to cytokine release syndrome, characterized by fever, hypotension, and increased liver enzymes.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroblastoma, including immunotherapy options. One notable approval is dinutuximab, a monoclonal antibody that targets the GD2 antigen on neuroblastoma cells, enhancing the immune system's ability to kill these cells. This is somewhat related to the approach of enhancing NK cell activity, as both strategies aim to boost the body's immune response against cancer cells. Other treatments include chemotherapy agents and combination therapies, but specific approvals for NK cell activity enhancement through TGFβ inhibition are not detailed.

What other types of research exist?

Promising novel alternatives for Neuroblastoma patients include: 1) Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown efficacy in other cancers like acute lymphoblastic leukemia. 2) Myostatin inhibitors, although preliminary trials have not yet demonstrated clinical benefit, they are being explored for muscle wasting diseases and could be adapted for Neuroblastoma. 3) Cell therapy with allogeneic cardiosphere-derived cells (CDCs), which has shown promise in Duchenne muscular dystrophy and could be explored for its anti-inflammatory effects in Neuroblastoma.

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Topoisomerase I inhibitors

NK Cell Infusion + Chemotherapy for Neuroblastoma (STING Trial)

Phase 1 & 2

Recruiting

Led By Mark Ranalli, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Myelosuppressive chemotherapy: At least 14 days since completion of myelosuppressive therapy

Measurable or evaluable disease must represent recurrent disease after therapy completion or progressive disease on therapy or refractory disease during induction

Must not have

Patients must not have been diagnosed with any other malignancy

Patients must not have uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that combines special immune cells with three cancer-fighting drugs. It aims to see if this combination is safe and effective for patients whose cancers are hard to treat with standard therapies.

Who is the study for?

This trial is for individuals under 30 years old with neuroblastoma or ganglioneuroblastoma, not just bone marrow disease. They must have adequate organ function and no recent treatments that conflict with the study drugs. Pregnant or breastfeeding individuals, those on certain medications, or with uncontrolled infections cannot participate.

What is being tested?

The trial tests how safe and tolerable it is to give universal donor NK cells combined with irinotecan, temozolomide, and dinutuximab to patients. It aims to see how well these patients respond after establishing safety in Phase 1 during the expanded Phase 2 cohort.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation in organs, infusion-related reactions like fever or chills, digestive issues including diarrhea (if beyond Grade 2 they can't join), blood disorders due to bone marrow suppression, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It's been over 2 weeks since my last strong chemotherapy.

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My cancer has returned or worsened despite treatment.

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My liver is functioning well, with normal bilirubin and ALT levels.

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I am under 30 years old.

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My heart's pumping ability is confirmed to be good by a heart scan.

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My cancer is confirmed as neuroblastoma or ganglioneuroblastoma with specific urine markers.

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My tumor can be seen on scans and shows activity on specific tests.

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My cancer got worse during my first intense treatment.

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My blood tests show enough neutrophils and platelets, and I haven't used specific growth factors recently.

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I don't need oxygen regularly and can breathe well at rest.

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My kidney function is within the required range.

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It's been over 4 weeks since I completed radiation on a targeted lesion.

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It has been over 6 weeks since my last MIBG therapy.

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My kidney function, measured by creatinine, is within the normal range for my age and gender.

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I haven't taken irinotecan or temozolomide in the last 6 months.

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I don't have trouble breathing at rest, don't need extra oxygen, and my oxygen levels are good.

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My condition has come back after treatment.

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I have had a stem cell infusion treated with a special process.

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My liver enzyme (ALT) levels are within the required range for the study.

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My diagnosis is neuroblastoma or ganglioneuroblastoma, confirmed by tests.

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It has been over 6 weeks since my last cellular therapy treatment.

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My brain-related side effects are mild.

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My cancer did not fully respond after 4 rounds of initial chemotherapy.

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I have received anti-GD2 monoclonal antibodies before.

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I am under 30 years old.

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My bilirubin levels are within normal range for my age.

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I have had a stem cell infusion treated with a special process.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with any cancer other than the one I am seeking treatment for.

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I do not have any infections that aren't responding to treatment.

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I do not have severe diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

NK cells safety and tolerability: Number of participants with treatment-related adverse events and toxicities

Response to NK Cell treatment as determine by CT/MRI imaging

Response to NK Cell treatment as determine by MIBG scans imaging

+1 more

Secondary study objectives

Toxicity Definition of NK cells

Other study objectives

Natural Killer Cells

Assessment of the phenotype of expanded NK cells for neuroblastoma patients

Correlation of persistence of NK cells after adoptive transfer with clinical outcomes

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment5 Interventions

The planned therapy will involve 6 cycles of 21 days each consisting of irinotecan, temozolomide, dinutuximab, sargramostim, and natural killer (NK) cells. Treatment cycles will be repeated every 21 days based upon disease response and toxicity criteria. Tumor response will be assessed after Cycles 2, 4 and 6. Patients who do not experience dose-limiting toxicities and achieve complete response, partial response or stable disease may continue to receive the assigned therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Irinotecan

2017

Completed Phase 3

~2590

Dinutuximab

2009

Completed Phase 3

~710

Sargramostim

2006

Completed Phase 4

~880

0 / 30Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuroblastoma treatments often include immunotherapy approaches such as natural killer (NK) cell-based therapies. These therapies leverage the body's immune system to target and destroy cancer cells. Specifically, NK cells can recognize and kill tumor cells without prior sensitization. The trial involving Universal Donor TGFβi NK Cells aims to enhance NK cell activity by inhibiting TGFβ, a cytokine that typically suppresses immune responses. By blocking TGFβ, the NK cells' ability to attack Neuroblastoma cells is improved, potentially leading to better treatment outcomes. This is crucial for Neuroblastoma patients as it offers a targeted approach that could reduce tumor burden and improve survival rates.

The State of Cellular Adoptive Immunotherapy for Neuroblastoma and Other Pediatric Solid Tumors.