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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
response rate (CR+PR)

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
2014
Completed Phase 4
~1340

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,760 Total Patients Enrolled
49 Trials studying Neuroblastoma
5,743 Patients Enrolled for Neuroblastoma
Y-mAbs TherapeuticsIndustry Sponsor
25 Previous Clinical Trials
1,509 Total Patients Enrolled
12 Trials studying Neuroblastoma
1,144 Patients Enrolled for Neuroblastoma
Y-Mabs, IncUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate count of participants enrolled in this clinical trial?

"This clinical research has stopped actively recruiting. The study was posted on June 12th, 2017 and last updated October 19th 2022. Currently there are 162 trials accepting patients with neuroblastoma and 445 studies admitting participants for Hu3F8 therapy."

Answered by AI

Are there precedents of research with Hu3F8?

"At the present moment, 445 active clinical trials are researching Hu3F8 with 75 at Phase 3. Of these studies, a majority is being conducted in Adelaide of South Australia; nevertheless, 12811 separate locations around the world have access to this medication for trial purposes."

Answered by AI

Are individuals currently being enrolled in this trial?

"This clinical trial has now ceased its search for new candidates, with the original advertisement posted on June 12th 2017 and last updated October 19th 2022. However, 162 other trials are actively recruiting patients diagnosed with neuroblastoma and 445 studies are still accepting participants for Hu3F8 therapy."

Answered by AI

What is the typical purpose for administering Hu3F8?

"Hu3F8 is frequently used to manage progression, disease. This immunotherapy can also provide therapeutic benefits for colorectal carcinoma, ovarian cancer, and other maladies such as advance directives."

Answered by AI
~1 spots leftby Jun 2024