Status:
COMPLETED
CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
Lead Sponsor:
University Children's Hospital Tuebingen
Conditions:
Neuroblastoma Recurrent
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief Summary
A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five consecutive days will be administered every 4 weeks, starting 60-180 days after previous haploidentical stem ce...
Eligibility Criteria
Inclusion
- Less than or equal to 21 years of age.
- Histologically confirmed neuroblastoma.
- Refractory to standard treatment (i.e. refractory disease) or relapse after previous autologous or allogenic stem cell transplantation.
- Patient has undergone haploidentical stem cell transplantation prior to antibody infusion according to appendix IV at least 60 days prior to starting immunotherapy.
- Serum glutamate pyruvate transaminase (SGPT) less than 2.5 times the upper limit of normal for age and total bilirubin less than 2 times the upper limit of normal for age. D-Dimers less than 2 times the upper limit of normal.
- Creatinine clearance or radioisotope GFR greater than or equal to 40 ml/min/1.73m2.
- Cardiac shortening fraction greater than or equal to 20% by echocardiogram. Karnofsky/Lansky performance score (age appropriate) of greater than or equal to 50.
- Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
- Written informed consent is obtained, and for minors a written agreement by parents or legal guardian.
Exclusion
- Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval \> 450 milliseconds).
- Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance.
- Patients with significant psychiatric disabilities or uncontrolled seizure disorders.
- Patients with active infections or active peptic ulcer, unless these conditions are corrected or controlled.
- Patients with acute GvHD Grade III or IV or extensive chronic GvHD.
- Patients with clinically significant, symptomatic, pleural effusions.
- Patients who have had major surgery, (i.e. laparotomy or thoracotomy) within the past two weeks.
- Patients who will more than 12 months post haploidentical stem cell transplantation at the time of starting the first cycle of immunotherapy.
- Prior administration of ch14.18 antibody after allogeneic stem cell transplantation (prior administration after autologous transplantation will be acceptable)
- HIV or Hepatitis B Surface (HBS) Ag positive. As presence of either may influence the ability if the immune system to be stimulated by this treatment.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02258815
Start Date
August 1 2010
End Date
December 1 2022
Last Update
December 8 2023
Active Locations (4)
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1
University Hospital Graz
Graz, Austria, 8036
2
St. Anna Childrens Hospital
Vienna, Austria, 1090
3
University Hospital Greifswald
Greifswald, Germany, 17475
4
University Hospital Tuebingen
Tübingen, Germany, 72076