Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With… (NCT05080790) | Clinical Trial Compass
CompletedPhase 2
Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma
Germany7 participantsStarted 2021-11-15
Plain-language summary
Dinutuximab beta was designed to bind to neuroblastoma cells and other cancer cells that express the GD2 antigen, such as STS/LMS cells, and it is believed that this binding "labels" the cells an makes them a better target.
In addition, γδ T cells can safely be expanded in-vivo using intravenous zoledronic acid and subcutaneous interleukin-2 (IL-2) in patients with different types of solid tumors \[Dieli et al., 2007; Pressey et al., 2016\].
It is supposed that combination treatment using dinutuximab beta, zoledronic acid and IL-2 is more effective than their use in isolation. The already-established safety profiles of these agents make testing of the combination in GD2 positive cancers such as GD2 expressing LMS both rational and feasible \[Fisher et al., 2015\].
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have histologically confirmed leiomyosarcoma.
✓. ≥ 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy (anthracycline-containing regimen).
✓. Patients must have a cryopreserved and formalin-fixed paraffin-embedded tumor sample available for submission to central pathology review.
✓. Signed Written Informed Consent.
✓. Men and women aged ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. Measurable disease.
✓. Locally advanced/unresectable or metastatic disease.
Exclusion criteria
✕. Symptomatic, untreated, or uncontrolled brain metastases present.
✕. Patients with a known history of hypersensitivity to interleukin-2.
What they're measuring
1
The primary objective of this study is to assess the feasibility of the combined treatment with dinutuximab beta, zoledronic acid and low-dose interleukin 2.
Timeframe: 3 years, at EOS
Trial details
NCT IDNCT05080790
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Patients with a hypersensitivity to zoledronic acid or to other bisphosphonates.
✕. Need for invasive dental procedures. Preventive dental exams should be performed before starting zoledronic acid.
✕. Patients after allogenic stem cell transplantation or other allogenic organ transplantation (e.g., liver, kidney etc.).
✕. Patients with different malignant diseases other than sarcoma (measurable manifestations in the last 12 months or active therapy against the other malignant disease in the last 12 months).
✕. Known active pulmonary disease with hypoxia defined as:
✕. Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection, or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures.