A Phase 2 interventional study of ch14.18/CHO in Neuroblastoma Recurrent, sponsored by University Children's Hospital Tuebingen. Completed at 4 sites in 2 countries. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by University Children's Hospital Tuebingen · Phase 2, Interventional, and Treatment
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 cell transplantation.
Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
This study's planned enrollment of 35 is close to the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →University Children's Hospital Tuebingen is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Creatinine clearance or radioisotope GFR greater than or equal to 40 ml/min/1.73m2.
Exclusion Criteria:
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. Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year.
Drug: ch14.18/CHO
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. Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year.
Also known as: ch14.18, anti GD2 antibody
Success of treatment
Primary endpoint is "success of treatment" defined as a patient receiving the full protocol treatment, still alive 180 days after treatment without progression and without unacceptable toxicity and acute GvHD \>= Grade III or extensive chronic GvHD. Thus, a composite variable is used as primary endpoint: Treatment success, is defined as a patients who did not experience 1. unacceptable toxicities 2. acute GvHD \>= Grade III or extensive chronic GvHD 3. other toxicities that did not recover to \<= Grade 1 within 4 weeks or 4. progressive disease after 6 cycles or 5. deaths within treatment after SCT 6. withdrawal due to other reasons
Time frame: 180 days
Anti tumour responses
• To evaluate the anti-tumour responses resulting from this immunotherapy regimen through clinical assessments (radiographic and clinical measurements, including bone marrow immunohistochemistry for those research participants with marrow involvement).
Time frame: 1 year
Pharmakoinetics
\* To evaluate pharmacokinetics of the ch14.18/CHO including analysis of cytokine levels in patients blood during administration. Antibody levels will be evaluated in determined intervals during Therapy
Time frame: 1 Year
NK Cell aktivation and proliferation
\* To evaluate changes in NK cell activation and proliferation (immunological monitoring) for additional support of potential Anti-tumor effect.
Time frame: 1 Year
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University Children's Hospital Tuebingen