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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ch14.18 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ch14.18/CHO | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| Pharmakoinetics |
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Inclusion Criteria:
Creatinine clearance or radioisotope GFR greater than or equal to 40 ml/min/1.73m2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lang, MD, PhD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Graz | Graz | 8036 | Austria | |||
| St. Anna Childrens Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36854071 | Derived | Flaadt T, Ladenstein RL, Ebinger M, Lode HN, Arnardottir HB, Poetschger U, Schwinger W, Meisel R, Schuster FR, Doring M, Ambros PF, Queudeville M, Fuchs J, Warmann SW, Schafer J, Seitz C, Schlegel P, Brecht IB, Holzer U, Feuchtinger T, Simon T, Schulte JH, Eggert A, Teltschik HM, Illhardt T, Handgretinger R, Lang P. Anti-GD2 Antibody Dinutuximab Beta and Low-Dose Interleukin 2 After Haploidentical Stem-Cell Transplantation in Patients With Relapsed Neuroblastoma: A Multicenter, Phase I/II Trial. J Clin Oncol. 2023 Jun 10;41(17):3135-3148. doi: 10.1200/JCO.22.01630. Epub 2023 Feb 28. | |
| 34367149 |
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| ID | Term |
|---|---|
| C112746 | dinutuximab |
| C000654310 | humanized 3F8 anti-GD2 monoclonal antibody |
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|
|
* 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 |
| 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. | 1 Year |
| Vienna |
| 1090 |
| Austria |
| University Hospital Greifswald | Greifswald | 17475 | Germany |
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
| Derived |
| Seitz CM, Flaadt T, Mezger M, Lang AM, Michaelis S, Katz M, Syring D, Joechner A, Rabsteyn A, Siebert N, Troschke-Meurer S, Zumpe M, Lode HN, Yang SF, Atar D, Mast AS, Scheuermann S, Heubach F, Handgretinger R, Lang P, Schlegel P. Immunomonitoring of Stage IV Relapsed Neuroblastoma Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation and Subsequent GD2 (ch14.18/CHO) Antibody Treatment. Front Immunol. 2021 Jul 22;12:690467. doi: 10.3389/fimmu.2021.690467. eCollection 2021. |