Racotumomab in Patients With High-risk Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02998983|
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : September 12, 2017
This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma that have achieved a complete or very good partial response after standard therapy. An additional cohort of children who could not achieve these response criteria or that relapsed after standard therapy but do not have progressive disease will receive Racotumomab together with metronomic chemotherapy.
The main objectives of this study are to determine the immune response after one-year duration immunization with Racotumomab, to describe the response of Racotumomab therapy in minimal residual disease (MRD) in bone marrow and to describe the toxicity profile of Racotumomab.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Racotumomab||Phase 2|
Neuroblastoma is the most common extra-cranial tumor in childhood but prognosis is still poor, even with the advances in its treatment.
New therapeutic strategies have been examined, and several immunotherapeutic approaches, including combined therapy with monoclonal antibodies (anti-GD2), intravenous interleukin-2 (Il-2) and intravenous granulocyte-macrophage colony-stimulating factor (GM-CSF), and anti-idiotype vaccines are currently being assessed.
Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies in patients with neuroblastoma.
The expression of the ganglioside N-glycolyl GM3 was shown in neuroblastoma and this expression could be useful as a specific target for immunotherapy.
Ractoumomab will be administered once standard therapy for neuroblastoma has been completed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Multicenter, Phase II Immunotherapy Study With Racotumomab in Patients With High-risk Neuroblastoma|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||June 2020|
Dosage form: intradermal injection. Dosage: 0.4 mg. Frequency: the first 5 doses: biweekly injections; the following 10 doses: monthly injections. Duration: 12 months
- Number of participants who elicit an immune response to a one-year immunization schedule of racotumomab in a cohort study of patients with high-risk neuroblastoma. [ Time Frame: 1 year ]
- Number of participants in whom minimally disseminated disease in the bone marrow decreases or disappears with a one-year immunization schedule of racotumomab compared to baseline values at study entry. [ Time Frame: 1 year ]
- Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 after a one-year immunization schedule of racotumomab when administered alone or together with onco-specific metronomic chemotherapy therapy. [ Time Frame: 1 year ]
- Pattern of expression of N-Glycolyl-GM3 gangliosides in tumor samples obtained at disease diagnosis and during follow up if available. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998983
|Hospital Universitario Austral||Recruiting|
|Pilar, Buenos Aires, Argentina, 1629|
|Contact: Guillermo Chantada, MD +542304482831 email@example.com|
|Prof. Dr. J. P. Garrahan National Children's Hospital||Recruiting|
|Buenos Aires, Argentina, 1245|
|Contact: Walter Cacciavillano, MD firstname.lastname@example.org|
|Principal Investigator: Walter Cacciavillano, MD|
|Principal Investigator:||Walter Cacciavillano, MD||Prof. Dr. J. P. Garrahan National Children's Hospital|