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New treatment option for Relapsed Neuroblastoma
Official title NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
ClinicalTrials.gov ID: NCT04211675
What this study is testing
What is Natural Killer Cells?
Natural Killer Cells is an investigational medicine, being studied as a potential treatment for relapsed 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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 29
You may be able to join if
- 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 bone marrow with or without elevated...
- 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...
You likely can't join if
- Patients who are pregnant or breastfeeding
- Patients with elevated catecholamines (\>2x ULN) only.
- 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.
See the full eligibility criteria
Who can join
- 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 bone marrow with or without 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
- 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...
- Measurable or evaluable disease must 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...
- 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
- 131I-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) people who have previously received anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging are...
- 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...
- 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
What rules you out
- Patients who are pregnant or breastfeeding
- Patients with elevated catecholamines (\>2x ULN) only.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, 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, up to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, 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.