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New treatment option for Neuroblastoma
Official title Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
ClinicalTrials.gov ID: NCT06995872
What this study is testing
What is rhIL-15?
rhIL-15 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 35
You may be able to join if
- ELIGIBILITY CRITERIA:
- Disease Requirements:
- Histologic diagnosis: Participants must have pathology-confirmed neuroblastoma (no time limit). Old reports and tissue blocks can be used if...
- Active disease status: Participants must have relapsed and/or refractory disease after receiving frontline chemotherapy and at least one salvage...
- Documentation of disease: Participants must have evaluable disease according to the International Neuroblastoma Response Criteria (INRC). This means...
You likely can't join if
- Presence of pericardial effusion.
- Chronic immunosuppression (physiologic steroid supplementation is allowed but any chronic immunosuppressant like steroids or other modulators are not...
- Major surgery within 4 weeks prior to initiation of study therapy
- Current/active human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.
- Current/active HBV/HCV infection as measured by seropositivity for Hepatitis C or positive for Hepatitis B surface antigen (HBsAg).
- History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biological composition to irinotecan and...
See the full eligibility criteria
Who can join
- ELIGIBILITY CRITERIA:
- Disease Requirements:
- Histologic diagnosis: Participants must have pathology-confirmed neuroblastoma (no time limit). Old reports and tissue blocks can be used if available. Confirmation of disease will be based on the review of pathology at...
- Active disease status: Participants must have relapsed and/or refractory disease after receiving frontline chemotherapy and at least one salvage treatment (can include dinutuximab, temozolomide, and/or irinotecan), with...
- Documentation of disease: Participants must have evaluable disease according to the International Neuroblastoma Response Criteria (INRC). This means they must have an area of active disease that can be identified by...
- Measurable tumors on magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable is defined as \>=10 mm in at least one dimension.
- Either 123MIBG-avid lesion detected on 123MIBG scan with positive uptake at a minimum of one site or FDG-PET-avid lesion detected on FDG-PET scan with positive uptake at a minimum of one site. This site must represent...
- Participants with resistant/refractory soft tissue disease that is not 123MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo a biopsy to document the presence of viable neuroblastoma. Biopsy...
- Participants with bone marrow disease in at least one sample from bilateral bone marrow biopsies will be eligible (documented neuroblastoma cells).
- Participants with a history of CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment.
- Prior Therapy: Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
- Chemo-immunotherapy: Participants are eligible if they have received prior therapy with dinutuximab/temozolomide/irinotecan, even if they may not have responded previously
- Myelosuppressive chemotherapy: Potential trial participants should have recovered from clinically significant myelosuppression.
- Non-chemotherapy anti-neoplastic agents: With anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts), sufficient time needs to have passed for the drug to have...
- Anti-GD2 antibody: toxicity related to prior antibody therapy must be recovered to grade \<=1.
- Radiation therapy: Given the possible negative effect of radiation on bone marrow cells and count recovery after chemotherapy, potential trial participants should have recovered from clinically significant...
- Stem cell transplants (SCT): After autologous stem cell transplants or stem cell infusions (including stem cell infusions given as supportive care following 131 I-MIBG therapy), all hematologic and other eligibility...
- 131I-MIBG therapy: After therapeutic 131 I-MIBG, all hematologic and other eligibility criteria must have been met.
- Participants who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days before study enrollment are not eligible. -Age Requirement:
- Age \>= 3 years and \<= 35 years at the time of enrollment. -Clinical Performance Status:
- Participants \>= 16 years of age: Karnofsky \>= 50 percent; Participants \ = 50 percent. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory to...
- Absolute neutrophil count: \>= 750/mcL (must be off of G-CSF for at least 1 week)
- Platelets: \>= 75,000/mcL (transfusion-independent, unless patient has bone marrow disease in which case transfusions are permitted to reach this threshold)
- Total bilirubin: \<=2 X ULN (except in the case of participants with documented Gilbert s disease \< 3x ULN)
- AST(SGOT)/ALT(SGPT): \<=3 X institutional upper limit of normal
- Creatinine: \<= the maximum for age listed in the table below OR
- Measured creatinine clearance: \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above the max listed below per age:
- Age (Years) \<=5, Maximum Serum Creatinine \<= 0.8 (mg/dL)
- Age (Years) 6 to \<= 10, Maximum Serum Creatinine \<=1.0 (mg/dL)
- Age (Years) \>10, Maximum Serum Creatinine \<= 1.2 (mg/dL)
- Cardiac function: Left ventricular ejection fraction \>= 52 percent.
- Pulmonary Function
- Baseline oxygen saturation \>92 percent on room air at rest
- Participants with respiratory symptoms clinically concerning for decreased pulmonary function must have a DLCO/adjusted \> 45 percent. For children who are unable to cooperate for PFTs, they must not have dyspnea at...
- Given the teratogenic effects of the therapy, participants of childbearing or child fathering potential must agree to be abstinent or use highly effective contraception (hormonal; intrauterine device; surgical...
- Participants who are nursing or plan to nurse must agree to discontinue/postpone nursing while on study therapy since it cannot be ruled out with certainty that any of the investigational drugs can be transmitted via...
- Ability of participant or parents/legal guardian to understand and sign a written informed consent document.
What rules you out
- Presence of pericardial effusion.
- Chronic immunosuppression (physiologic steroid supplementation is allowed but any chronic immunosuppressant like steroids or other modulators are not allowed)
- Major surgery within 4 weeks prior to initiation of study therapy
- Current/active human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.
- Current/active HBV/HCV infection as measured by seropositivity for Hepatitis C or positive for Hepatitis B surface antigen (HBsAg).
- History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biological composition to irinotecan and temozolomide used in study.
- Participants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
- Positive serum or urine beta-HCG pregnancy test performed at screening due to the teratogenic effects of chemotherapy.
- Participants with a prior or concurrent malignancy whose natural history or treatment with the safety or how well it works assessment of the investigational regimen.
- Participants with \>= grade 2 diarrhea at the time of entry.
- Participants who are unable to tolerate oral/nasogastric/gastrostomy medications. Additionally, participants with significant malabsorption will not be eligible for this trial.
- Participants with uncontrolled infection.
- Participants with a history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.