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Neuroblastoma RecurrentPhase 2NCT02258815

CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma

A Phase 2 study testing ch14.18/CHO in people with Neuroblastoma Recurrent, run by University Children's Hospital Tuebingen at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 21 years
Conditions the study is for
Neuroblastoma Recurrent
What is being tested?
ch14.18/CHO
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
4 sitesin 2 countries
Study dates
Aug 2010to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Austria2 sites

  • University Hospital Graz

    Graz, 8036

  • St. Anna Childrens Hospital

    Vienna, 1090

Other trials in Austria

Germany2 sites

  • University Hospital Greifswald

    Greifswald, 17475

  • University Hospital Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

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

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

Being tested
ch14.18/CHO
Keywords
pediatric, haploidentical, stem cell transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ch14.18/CHODrug

    Also called ch14.18, anti GD2 antibody

    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.

Study groups in NCT02258815
Study groupRoleWhat they receive
ch14.18ExperimentalA 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.
Receives: Drug: ch14.18/CHO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 180 days

Secondary outcomes (3)

  1. 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).

    Measured: 1 year

  2. 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

    Measured: 1 Year

  3. NK Cell aktivation and proliferation

    • To evaluate changes in NK cell activation and proliferation (immunological monitoring) for additional support of potential Anti-tumor effect.

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2014 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2018
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02258815
Sponsor's protocol ID
EudraCT:2009-015936-14
Status last verified
Dec 2023
First submitted
7 Aug 2013
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36854071

  • 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.

    PubMed 34367149

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ch14.18/CHO in people with Neuroblastoma Recurrent, run by University Children's Hospital Tuebingen at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of treatment (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02258815, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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