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Completed

NCT Number: NCT02258815

CH14.18 1021 Antibody and IL2 After Haplo SCT 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

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Key information

Conditions

Neuroblastoma Recurrent

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ch14.18, anti GD2 antibody

Primary outcomes

  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

    • unacceptable toxicities
    • acute GvHD >= Grade III or extensive chronic GvHD
    • other toxicities that did not recover to <= Grade 1 within 4 weeks or
    • progressive disease after 6 cycles or
    • deaths within treatment after SCT
    • withdrawal due to other reasons

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital Tuebingen

Other

Registry information

Official study title

Phase II Feasability Study Using ch14.18/CHO Antibody and Subcutaneous Interleukin 2 After Haploidentical Stem Cell Transplantation in Children With Relapsed Neuroblastoma

Important dates

Study start
2010
Primary completion
2018
Study completion
2022
First posted
Oct 7, 2014
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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