Actively Recruiting
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
Led by New Approaches to Neuroblastoma Therapy Consortium · Updated on 2026-03-23
62
Participants Needed
13
Research Sites
728 weeks
Total Duration
On this page
Sponsors
N
New Approaches to Neuroblastoma Therapy Consortium
Lead Sponsor
N
Nationwide Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
CONDITIONS
Official Title
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 to 31 years at enrollment
- Diagnosis of neuroblastoma confirmed by tissue biopsy or bone marrow involvement with increased urinary catecholamines
- High-risk neuroblastoma by COG classification at study registration
- Evidence of recurrent, progressive, refractory, or persistent high-risk neuroblastoma meeting specific disease status criteria
- At least one measurable lesion in bone, bone marrow, or soft tissue confirmed by imaging or biopsy
- Lansky (for patients 16 years and younger) or Karnofsky (for patients older than 16) performance score of 50 or higher
- Fully recovered from acute effects of prior chemotherapy, immunotherapy, or radiotherapy
- No recent receipt of certain therapies within specified time frames before registration, including chemotherapy, monoclonal antibodies, cellular therapy, radiation, stem cell transplant, investigational agents, and CYP3A4 modulators
- Adequate blood counts and transfusion independence
- Adequate kidney, liver, heart, and lung function as defined by study criteria
- Negative pregnancy test for females of childbearing potential and use of effective contraception during study participation
- No active central nervous system disease or stable CNS disease without symptoms
You will not qualify if you...
- Pregnant or breastfeeding patients, or those unwilling to use effective contraception
- Inability to comply with study safety monitoring
- Significant disease affecting major organs that would interfere with treatment
- Grade 3 or higher diarrhea
- Prior allogeneic stem cell or solid organ transplant
- Patients on hemodialysis
- Active or uncontrolled infections
- Known HIV, hepatitis B, or hepatitis C infection
- Diagnosis of any other malignancy
- History of severe allergic reactions to anti-GD2 antibody therapy
- Progressive disease while receiving certain prior therapies
- Refusal to participate in the NANT biology study without waiver
- Recent use of systemic steroids or other immunosuppressive medications unless exceptions apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Actively Recruiting
2
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94143
Not Yet Recruiting
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
4
Comer Children's Hospital, University of Chicago
Chicago, Illinois, United States, 60614
Not Yet Recruiting
5
Boston Children's Hospital, Dana-Farber Cancer Institute.
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
6
C.S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
7
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Not Yet Recruiting
8
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
9
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
Actively Recruiting
10
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Not Yet Recruiting
11
University of Texas Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
12
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
13
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
Research Team
A
Araz Marachelian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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