NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (STING)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2025
  • participants needed
    31
  • sponsor
    Nationwide Children's Hospital
Updated on 7 October 2022

Summary

This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.

Details
Condition Relapsed Neuroblastoma, Refractory Neuroblastoma
Treatment Temozolomide, Irinotecan, sargramostim, Dinutuximab, Natural killer cells
Clinical Study IdentifierNCT04211675
SponsorNationwide Children's Hospital
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Less than 30 years of age when registered on the study
Patients must have a histologic verification of neuroblastoma (NBL) or ganglioneuroblastoma or NBL cells in one marrow with elevated urine catecholamines
Life expectancy >2 months, AND one of the following
Recurrent disease; or
First episode of progressive disease (new lesion, increase in size, previous negative bone marrow) during initial multi-drug, induction myelosuppressive therapy; or
Primary resistant/refractory disease (partial, mixed, stable response criteria met) after completing at least 4 cycles of induction multi-drug induction chemotherapy; AND
One of the following
Patients must have measurable or evaluable tumor defined as: a) Measurable tumor on MRI or CT obtained within 4 weeks prior to study entry; Measurable is defined as ≥ 10mm in at least one dimension AND that has positive uptake on I-123 MIBG scan ("MIBG avid") or demonstrates increased FDG uptake on 18F-FDG PET-CT or PET-MRI ("PET-avid"); OR b) Evaluable tumor by I-123 MIBG scan within 4 weeks prior to study entry, defined as positive uptake at a minimum of one site
Measurable or evaluable disease ust represent recurrent disease after therapy completion or progressive disease on therapy or refractory disease during induction
Patients with refractory disease that are not avid on MIBG scan and do not have increased FDG uptake on PET must have biopsy proven viable NBL
New soft tissue sites that are MIBG avid or PET avid do not require biopsy as long as initial histologically-confirmed NBL diagnosis prior to current therapy
Patients must have progressed during or following completion of frontline therapy
Agents considered to be a part of frontline therapy would include
chemotherapy, radiation therapy, autologous stem cell transplantation
retinoids, immunotherapy with anti GD2 agents, cellular therapies, or I-131
MIBG, and frontline therapy is defined as any combination of these agents
defined in published regimens or current cooperative group clinical trials for
the successful treatment of that cancer."Therapy may not have been received
more recently than the timeframes defined below
Myelosuppressive chemotherapy: At least 14 days since completion of myelosuppressive therapy
Biologic: At least 7 days since completion of therapy with non-myelosuppressive biologic or retinoid
Radiation: At least 4 weeks since completion of radiation to any site identified as a target lesion. Palliative radiation is allowed to sites not used to measure response
Stem Cell Transplant (SCT): At least 6 weeks after autologous stem cell transplant or stem cell infusions as long as hematologic criteria have been met
I-MIBG Therapy: At least 6 weeks after therapeutic MIBG treatment
Cellular therapies: At least 6 weeks after any cellular therapy treatment (e.g., prior NK, CAR-T therapy)
Adequate bone marrow function, defined as
Peripheral absolute neutrophil count (ANC) ≥500/microL. Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days or short-acting myeloid growth factors (e.g., Neupogen) within 7 days of study entry
Platelet count ≥50,000/microL (transfusion independent for at least 1 week)
Adequate renal function defined as
Creatinine clearance or estimated radioisotope GFR ≥70 ml/min/1.73m2 or
Serum creatinine < 2x upper limit of normal (ULN) based on age/gender
Adequate liver function defined as
Total bilirubin <1.5x ULN for age AND
SGPT (ALT) ≤5x ULN for age (or ≤225 U/L). For purpose of this study, the ULN for SGPT (ALT) is 45 U/L
Adequate central nervous system function defined as
Patients with seizure disorders may be enrolled if seizures are well controlled on anti-convulsants
CNS toxicity ≤ Grade 2
Adequate cardiac function defined as
Shortening fraction of ≥ 27% by ECHO OR
Ejection fraction ≥ 50% by ECHO or gated radionuclide study
Adequate pulmonary function defined as
No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry

Exclusion Criteria

Patients who are pregnant or breastfeeding
Patients with elevated catecholamines (>2x ULN) only or bone marrow disease
Patients must not have received 0.5 mg/ kg/ day (prednisone equivalent) doses of systemic steroids for at least 7 days prior to enrollment
Patients must not have received CYP3A4 inducer or inhibitor for at least 7 days prior to study enrollment
Patients must not have been diagnosed with any other malignancy
Patients must not have > Grade 2 diarrhea
Patients must not have uncontrolled infection
Patients with history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required discontinuation of anti-GD2 therapy
Patients with a significant illness that is not covered by the exclusion criteria or that is expected to interfere with the action of study agents or to increase the severity of the toxicities experienced from the study treatment
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