Your session is about to expire
← Back to Search
Monoclonal Antibodies
Chemoimmunotherapy for Neuroblastoma
Phase < 1
Waitlist Available
Led By Shakeel Modak, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High-risk NB as defined by specific criteria including different stages and MYCN amplification status
Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
Must not have
Existing severe major organ dysfunction ≥ grade 3 except for specific conditions
Active life-threatening infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing whether adding the drug Hu3F8 to standard chemotherapy drugs irinotecan and temozolomide can help treat cancer with fewer side effects.
Who is the study for?
This trial is for children and adults with high-risk neuroblastoma, a type of cancer. Participants must have specific stages of the disease, measurable or evaluable disease after prior therapy, and cannot be in complete remission. They can't join if they have severe organ damage, low blood counts, allergies to mouse proteins, active infections or are pregnant/breastfeeding.
What is being tested?
The study tests an experimental drug called Hu3F8 combined with chemotherapy drugs irinotecan and temozolomide plus GM-CSF to see if this mix is safe and effective against neuroblastoma.
What are the potential side effects?
Possible side effects include reactions related to immune response from Hu3F8, digestive issues from irinotecan and temozolomide, bone marrow suppression leading to lower blood cell counts, as well as general fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My neuroblastoma is considered high-risk based on its stage and genetic features.
Select...
My neuroblastoma diagnosis is confirmed by tissue tests or bone marrow and urine tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My major organs are functioning well, with no severe issues.
Select...
I do not have a severe infection that is threatening my life.
Select...
I am not pregnant or breastfeeding.
Select...
My cancer is responding very well to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
response rate (CR+PR)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)Experimental Treatment4 Interventions
Each cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Temozolomide
FDA approved
GM-CSF
2011
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Y-mAbs TherapeuticsIndustry Sponsor
25 Previous Clinical Trials
1,509 Total Patients Enrolled
13 Trials studying Neuroblastoma
1,204 Patients Enrolled for Neuroblastoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,452 Total Patients Enrolled
50 Trials studying Neuroblastoma
5,784 Patients Enrolled for Neuroblastoma
Y-Mabs, IncUNKNOWN
Shakeel Modak, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
336 Total Patients Enrolled
7 Trials studying Neuroblastoma
279 Patients Enrolled for Neuroblastoma