We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02258815
Recruitment Status : Unknown
Verified October 2014 by Peter Lang, University Children's Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Peter Lang, University Children's Hospital Tuebingen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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


Condition or disease Intervention/treatment Phase
Neuroblastoma Recurrent Drug: ch14.18/CHO Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Feasability Study Using ch14.18/CHO Antibody and Subcutaneous Interleukin 2 After Haploidentical Stem Cell Transplantation in Children With Relapsed Neuroblastoma
Study Start Date : August 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ch14.18

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.

Other Names:
  • ch14.18
  • anti GD2 antibody


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Success of treatment [ Time Frame: 180 days ]

    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


Secondary Outcome Measures :
  1. Anti tumour responses [ Time Frame: 1 year ]
    • 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).

  2. Pharmakoinetics [ Time Frame: 1 Year ]
    * 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

  3. NK Cell aktivation and proliferation [ Time Frame: 1 Year ]
    * To evaluate changes in NK cell activation and proliferation (immunological monitoring) for additional support of potential Anti-tumor effect.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT02258815


Contacts
Layout table for location contacts
Contact: Peter Lang, MD, PhD +4970712983781 peter.lang@med.uni-tuebingen.de

Locations
Layout table for location information
Austria
University Hospital Graz Recruiting
Graz, Austria, 8036
Contact: Wolfgang Schwinger, MD, PhD    +43 31638512605    wolfgang.schwinger@medunigraz.at   
Principal Investigator: Wolfgang Schwinger, MD, PhD         
St. Anna Childrens Hospital Recruiting
Vienna, Austria, 1090
Contact: Ruth Ladenstein, MD, PhD    43 1 40470 3250    ruth.ladenstein@ccri.at   
Principal Investigator: Ruth Ladenstein, MD, PhD         
Germany
University Hospital Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Holger Lode, MD, PhD    +49 3834866301    lode@uni-greifswald.de   
Principal Investigator: Holger Lode, MD, PhD         
University Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Peter Lang, MD, PhD    +4970712983781    peter.lang@med.uni-tuebingen.de   
Principal Investigator: Peter Lang, MD, PhD         
Sponsors and Collaborators
University Children's Hospital Tuebingen
Investigators
Layout table for investigator information
Principal Investigator: Peter Lang, MD, PhD University Hospital Tuebingen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Peter Lang, Head of stem cell transplantation unit, University Children's Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02258815    
Other Study ID Numbers: EudraCT:2009-015936-14
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Peter Lang, University Children's Hospital Tuebingen:
pediatric
haploidentical
stem cell transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Dinutuximab
Antineoplastic Agents