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Monoclonal Antibodies

Combination Therapy for Neuroblastoma

Q: For what medical conditions is radiation therapy commonly prescribed?

In the case of Kaposi's <a href="https://www.withpower.com/clinical-trials/sarcoma">Sarcoma</a> <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a>-related, radiation therapy is frequently utilized in treatment. Moreover, this form of medical intervention has also been used to address Merkel cell cancer, <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, and <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>.

Q: To what degree do the risks of radiation therapy outweigh its potential benefits?

The safety of radiation therapy was judged to be a 2 on our scale, as Phase 2 trials have only produced data indicating its security but not its efficacy.

Q: Is this an unprecedented clinical trial?

Since 1997, radiation therapy has been studied extensively. Alfacell sponsored the original experiment involving 300 participants in that year and later it would be approved for Phase 3 drug trials with 1950 active studies spanning 3782 cities within 81 countries.

Q: What are the fundamental aims of this investigation?

The primary aim of this 3-year clinical trial is to assess the number of participants with complete or partial response. Secondary objectives include exploring whether it is possible to deliver hu14.18K322A in 6 induction therapy cycles, ascertaining dose limiting toxicities (DLT) and severe grade 3/4 veno-occlusive disease (VoD), as well as measuring local failure rate at the site of treatment.

Q: What is the maximum eligibility for recruitment into this experiment?

This trial is not currently enrolling patients. It was initially posted on July 5, 2013 and most recently updated April 7th, 2022. If you are exploring alternative clinical trials that may be appropriate for your condition or treatment plan, there are 161 studies related to <a href="https://www.withpower.com/clinical-trials/neuroblastoma">neuroblastoma</a> and 1950 radiation therapy studies actively recruiting participants.

Q: Is the enrollment for this experiment still open to potential participants?

At this moment, enrollment in the trial has been halted. Its inaugural posting was on July 5th 2013 and its latest update took place April 7th 2022. 161 studies related to <a href="https://www.withpower.com/clinical-trials/neuroblastoma">neuroblastoma</a> are actively recruiting subjects, while 1950 trials for radiation therapy have open spots at present.

Phase 2

Waitlist Available

Led By Wayne L. Furman, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed, advanced stage, high-risk neuroblastoma meeting specific criteria including age, INSS stage, MYCN amplification, and biologic features

Participants <19 years of age (eligible until 19th birthday)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new monoclonal antibody (mAb) to see if it is effective in treating neuroblastoma, a cancer that commonly affects children. The mAb targets a protein that is found on the surface of neuroblastoma cells.

Who is the study for?

This trial is for children under 19 with high-risk neuroblastoma, a type of cancer. They must have specific stages of the disease and certain genetic features like MYCN amplification. Kids who've had no prior treatment except in emergencies can join. Parents may donate cells if they're over 18. Children with severe diseases or girls who are pregnant can't participate.Check my eligibility

What is being tested?

The trial tests a new antibody called hu14.18K322A combined with chemotherapy to see if it helps kids with neuroblastoma enter remission (disease improvement). It also looks at whether this treatment extends the time patients live without their disease getting worse and how well radiation therapy works on abdominal tumors.See study design

What are the potential side effects?

Possible side effects include reactions to the monoclonal antibody such as inflammation, allergic responses, and discomfort at infusion sites; chemotherapy-related issues like nausea, hair loss, blood cell count changes; and risks from stem cell transplant procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been newly diagnosed with advanced, high-risk neuroblastoma.

Select...

I am under 19 years old.

Select...

My child's cancer progressed to stage 4 without chemotherapy after initial diagnosis.

Select...

My cancer diagnosis was confirmed with specific tests for neuroblastoma.

Select...

I have not had any treatment before, except in an emergency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Event-free Survival (EFS)

Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]

Secondary outcome measures

Dose Limiting Toxicity (DLT)

Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation

Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment21 Interventions

Participants receive IV hu14.18K322A with each course of chemotherapy (cyclophosphamide, topotecan, cyclophosphamide, doxorubicin, vincristine, cisplatin, and etoposide). Mesna will be given prior to and after cyclophosphamide infusion. Peripheral blood stem cell harvest (PBSC) and surgical resection of primary tumor will be performed, if feasible. Intensification therapy includes busulfan, melphalan, and levetiracetam with peripheral blood stem cell transplantation. A course of hu14.18K322A with natural killer cell infusion will be given to consenting participants. Radiation therapy will follow PBSC transplant with the exception of any patient requiring emergent radiotherapy. MRD treatment includes hu14.18K322A, G-CSF, GM-CSF, interleukin-2 and isotretinoin. Cells for infusion are prepared using the CliniMACS System.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

vincristine

2005

Completed Phase 4

~3840

busulfan

1999

Completed Phase 3

~3630

radiation therapy

1994

Completed Phase 3

~13390

interleukin-2

2009

Completed Phase 3

~450

natural killer cell infusion

2013

Completed Phase 2

~80

GM-CSF

2014

Completed Phase 4

~1340

mesna

1992

Completed Phase 3

~1420

melphalan

1994

Completed Phase 3

~3530

doxorubicin

2005

Completed Phase 3

~9130

peripheral blood stem cell transplantation

1997

Completed Phase 3

~4330

Isotretinoin

2019

Completed Phase 4

~3520

etoposide

1994

Completed Phase 3

~9300

levetiracetam

2008

Completed Phase 4

~920

surgical resection

2016

Completed Phase 3

~280

cisplatin

1997

Completed Phase 3

~3290

G-CSF

2014

Completed Phase 4

~1610

CliniMACS

2005

Completed Phase 3

~770

cyclophosphamide

1994

Completed Phase 3

~8140

topotecan

2009

Completed Phase 3

~870

hu14.18K322A

2014

Completed Phase 1

~10

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cookies for Kids' CancerOTHER

6 Previous Clinical Trials

205 Total Patients Enrolled

1 Trials studying Neuroblastoma

65 Patients Enrolled for Neuroblastoma

CURE Childhood Cancer, Inc.OTHER

4 Previous Clinical Trials

76 Total Patients Enrolled

2 Trials studying Neuroblastoma

57 Patients Enrolled for Neuroblastoma

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,306,424 Total Patients Enrolled

23 Trials studying Neuroblastoma

6,871 Patients Enrolled for Neuroblastoma

Media Library

hu14.18K322A (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01857934 — Phase 2

Neuroblastoma Research Study Groups: Treatment

Neuroblastoma Clinical Trial 2023: hu14.18K322A Highlights & Side Effects. Trial Name: NCT01857934 — Phase 2

hu14.18K322A (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01857934 — Phase 2

Frequently Asked Questions

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

For what medical conditions is radiation therapy commonly prescribed?

"In the case of Kaposi's Sarcoma AIDS-related, radiation therapy is frequently utilized in treatment. Moreover, this form of medical intervention has also been used to address Merkel cell cancer, leukemia, and prostate cancer."

Answered by AI

To what degree do the risks of radiation therapy outweigh its potential benefits?

"The safety of radiation therapy was judged to be a 2 on our scale, as Phase 2 trials have only produced data indicating its security but not its efficacy."

Answered by AI

Is this an unprecedented clinical trial?

"Since 1997, radiation therapy has been studied extensively. Alfacell sponsored the original experiment involving 300 participants in that year and later it would be approved for Phase 3 drug trials with 1950 active studies spanning 3782 cities within 81 countries."

Answered by AI

What are the fundamental aims of this investigation?

"The primary aim of this 3-year clinical trial is to assess the number of participants with complete or partial response. Secondary objectives include exploring whether it is possible to deliver hu14.18K322A in 6 induction therapy cycles, ascertaining dose limiting toxicities (DLT) and severe grade 3/4 veno-occlusive disease (VoD), as well as measuring local failure rate at the site of treatment."

Answered by AI

What is the maximum eligibility for recruitment into this experiment?

"This trial is not currently enrolling patients. It was initially posted on July 5, 2013 and most recently updated April 7th, 2022. If you are exploring alternative clinical trials that may be appropriate for your condition or treatment plan, there are 161 studies related to neuroblastoma and 1950 radiation therapy studies actively recruiting participants."

Answered by AI

Is the enrollment for this experiment still open to potential participants?

"At this moment, enrollment in the trial has been halted. Its inaugural posting was on July 5th 2013 and its latest update took place April 7th 2022. 161 studies related to neuroblastoma are actively recruiting subjects, while 1950 trials for radiation therapy have open spots at present."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Longitudinal NK Cell Kinetics and Cytotoxicity in Children with Neuroblastoma Enrolled in a Clinical Phase II Trial

Nguyen, Rosa, Natasha Sahr, April Sykes, Mary Beth McCarville, Sara M Federico, Amanda Sooter, David Cullins, et al.. 2020. “Longitudinal NK Cell Kinetics and Cytotoxicity in Children with Neuroblastoma Enrolled in a Clinical Phase II Trial”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2019-000176.

Journal of Clinical OncologyJournal

Improved Outcome in Children with Newly Diagnosed High-risk Neuroblastoma Treated with Chemoimmunotherapy: Updated Results of a Phase II Study Using Hu14.18k322a

Furman, Wayne L., Beth McCarville, Barry L. Shulkin, Andrew Davidoff, Matthew Krasin, Chia-Wei Hsu, Haitao Pan, et al.. 2022. “Improved Outcome in Children with Newly Diagnosed High-risk Neuroblastoma Treated with Chemoimmunotherapy: Updated Results of a Phase II Study Using Hu14.18k322a”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01375.

clinicaltrials.govStudy

Therapy for Children With Advanced Stage Neuroblastoma

2013. "Therapy for Children With Advanced Stage Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01857934.

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