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Tests treatment safety and results for Neuroblastoma Recurrent
Official title A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma
ClinicalTrials.gov ID: NCT07085338
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma recurrent.
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
- The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed). Primary Aims To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible and tolerable To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF Secondary Aims To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 30
You may be able to join if
- Age \- Patients must be \ 2 x upper limit of normal (ULN)], at the time of initial diagnosis. Disease Risk Group
- Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was...
- Recurrent/progressive disease after the diagnosis of high-risk neuroblastoma at any time prior to enrollment regardless of response to frontline...
- Refractory disease: A best overall response of no response/stable disease since diagnosis of high-risk neuroblastoma AND after at least 4 cycles of...
- Persistent disease: A best overall response of partial response since diagnosis of high-risk neuroblastoma AND after at least 4 cycles of induction...
You likely can't join if
- \- Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study due to risks of...
- \- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- \- Patients with disease of any major organ system that would compromise their ability to withstand therapy.
- \- Patients who have undergone a prior allogeneic stem cell or solid organ transplant.
- \- Patients who are on hemodialysis.
- \- Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative...
See the full eligibility criteria
Who can join
- Age \- Patients must be \ 2 x upper limit of normal (ULN)], at the time of initial diagnosis. Disease Risk Group
- Patients must have high-risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but were then reclassified as...
- Recurrent/progressive disease after the diagnosis of high-risk neuroblastoma at any time prior to enrollment regardless of response to frontline therapy. (Note that this excludes patients initially considered low or...
- Refractory disease: A best overall response of no response/stable disease since diagnosis of high-risk neuroblastoma AND after at least 4 cycles of induction therapy.
- Persistent disease: A best overall response of partial response since diagnosis of high-risk neuroblastoma AND after at least 4 cycles of induction therapy Sites of Disease \- Patients must have at least ONE of the...
- MIBG avid tumors: patients must meet one of the following criteria: a. Patients with recurrent/progressive or refractory disease: i. Must have at least one MIBG avid bone site on planar imaging OR ii. Must have \> 2...
- For MIBG non-avid tumors, patients must have at least an FDG-PET avid site and meet the following criteria:
- Biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment of at least one FDG-PET avid site. Bone Marrow \- Any amount of tumor cells in the bone marrow (including neuroblasts...
- SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter ≥ 10 mm, or for discrete lymph nodes ≥ 15mm on short axis. Lesions meeting size criteria will be considered measurable.
- In addition to size, a lesion needs to meet ONE of the following criteria except for patients with parenchymal CNS lesions which will only need to meet size criteria: a. For MIBG avid tumors: lesion must be MIBG avid...
- If a patient has 3 or more MIBG avid soft tissue lesions, then no biopsy is required.
- If a patient has only 1 or 2 MIBG avid soft tissue lesion sites) then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one MIBG avid site present at the time of enrollment is required. Soft...
- Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts) Concomitant Therapy Restrictions \- Patients must not have received the concomitant medications indicated...
- No other anti-cancer agents or radiotherapy at the time of study registration or while on study.
- No short-acting hematopoietic growth factors within 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors within 14 days of blood draw documenting eligibility.
- Patients must not have received 0.5 mg/kg/day (prednisone equivalent) doses of systemic steroids for at least 7 days prior to study enrollment.
- Inhaled steroids are permitted to treat reactive airways
- \< 2mg/kg of hydrocortisone or equivalent is permitted as blood product premedication to avoid allergic reactions.
- Physiologic hydrocortisone dosing is permitted for patients with known adrenal insufficiency.
- The use of dexamethasone as an antiemetic is not permitted.
- Irinotecan is a substrate for CYP3A4 (major) and CYP2B6 (major). Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment are not eligible. The use of...
- Moderate inducers or inhibitors of CYP3A4 (Appendix II) should also be avoided during protocol therapy if reasonable alternatives exist. Organ Function Requirements Hematologic Function: \- Patients must meet the...
- ANC ≥750/μL, (no short-acting hematopoietic growth factors ≤ 7 days of blood draw documenting eligibility and no long-acting hematopoietic growth factors ≤ 14 days of blood draw documenting eligibility); and
- Platelet count ≥ 75,000/μL, transfusion independent (no platelet transfusions ≤ 7 days of blood draw documenting eligibility). Renal Function a. Patients must have adequate renal function defined as age-adjusted serum...
- Total bilirubin ≤ 1.5 x ULN for age; and,
- SGPT (ALT) ≤ 225 U/L (≤ 5x ULN). Note that for ALT, the upper limit of normal for all sites is defined as 45 U/L. Cardiac Function
- Shortening fraction of ≥ 27% by ECHO, or
- Ejection fraction of ≥ 50% by ECHO or gated radionuclide study. Pulmonary Function No evidence of dyspnea at rest, no exercise intolerance. Adequate Central Nervous System Function
- Patients with a history of CNS disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment
- Patients with seizure disorders may be enrolled if seizures are well controlled on anti-seizure medications
- CNS toxicity ≤ Grade 2 Reproductive Function \- All post-menarchal females must have a negative serum or urine beta-HCG ≤ 7 days prior to registration. Male and female people of reproductive age and childbearing...
What rules you out
- \- Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study due to risks of fetal and teratogenic adverse events. Females of childbearing potential...
- \- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- \- Patients with disease of any major organ system that would compromise their ability to withstand therapy.
- \- Patients who have undergone a prior allogeneic stem cell or solid organ transplant.
- \- Patients who are on hemodialysis.
- \- Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative, afebrile, and meet other organ function criteria.
- \- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicions.
- \- Patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible. The only exception is for patients known to require 2 mg/kg or...
- \- Patients on any other immunosuppressive medications (e.g., cyclosporine, tacrolimus) are not eligible.
- \- Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, or carbamazepine for at least 7 days prior to study enrollment. Patients receiving non-enzyme inducing...
- \- Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment are not eligible.
- \- Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma.
- \- Patients with symptoms of congestive heart failure are not eligible.
- \- Patients must not have \> Grade 2 diarrhea.
- \- Patients with a history of progressive disease while receiving therapy per ANBL1221 (irinotecan/temozolomide/dinutuximab/GMCSF).
- \- Patients with a history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy are not eligible.
- \- Patients with elevated catecholamines (i.e., \> 2 x ULN) only and no evidence of disease are NOT eligible for this study.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Colorado Springs, Colorado, United States
- Ann Arbor, Michigan, United States
- Memphis, Tennessee, 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 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Colorado Springs, Colorado, United States; Ann Arbor, Michigan, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
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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.