CLINICUM
Clinical Trials in the Upper Midwest for Pediatric Hematology, Oncology and BMT

Neuroblastoma

The Children's Hospital University of Illinois

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Northwestern University - Ann and Robert H. Lurie Children's Hospital of Chicago

Medical College of Wisconsin - Children's Hospital of Wisconsin

  • Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid Tumors (STIR)

    The investigators hypothesize that this Phase 2 cellular and adoptive immunotherapy study using human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplantation (HCT) followed by an early, post-transplant infusion of donor natural killer (NK) cells on Day +7 will not only be well-tolerated in this heavily-treated population (safety), but will also provide a mechanism to treat high-risk solid tumors, leading to improved disease control rate (efficacy). Disease control rate is defined as the combination of complete (CR) and partial (PR) response and stable disease (SD). The investigators further propose that this infusion of donor NK cells will influence the development of particular NK and T cell subtypes which will provide immediate/long-term tumor surveillance, infectious monitoring, and durable engraftment. Patients with high-risk solid tumors (Ewings Sarcoma, Neuroblastoma and Rhabdomyosarcoma) who have either measurable or unmeasurable disease and have met eligibility will be enrolled on this trial for a goal enrollment of 20 patients over 4 years.

    August 19, 2020
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Rush University Children's Hospital

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University of Chicago - Comer Children's Hospital

  • NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)

    Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).

    August 24, 2020

  • Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

    Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

    August 24, 2020

  • 131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS. 131I-MIBG With Vorinistat (N2011-01)

    This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.

    August 24, 2020

  • N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan (DFMO)

    This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan. To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects. To find out the side effects seen by giving DFMO at different dose levels with celecoxib, cyclophosphamide and topotecan. To measure the levels of DFMO in the blood at different dose levels. To determine if your tumor gets smaller after treatment with DFMO, celecoxib, cyclophosphamide and topotecan. To determine if specific gene changes in you or your tumor makes you more prone to side effects or affects your tumor's response to the combination of DFMO, celecoxib, cyclophosphamide and topotecan. To determine if the amount of normal chemicals in your body called polyamines go down in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more likely to have a good response to the treatment if they do.

    August 24, 2020

  • MIBG With Dinutuximab

    131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I dose escalation 3+3 design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients may then be enrolled.

    August 24, 2020
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University of Iowa - Stead Family Children's Hospital

  • A Study of Therapeutic Iobenguane (131-I) for Relapsed, High-Risk Neuroblastoma Subjects (OPTIMUM)

    The purpose of this study is to evaluate the efficacy and safety of 131I-MIBG in patients with neuroblastoma, who relapsed.

    August 24, 2020

  • Theranostics: 68GaDOTATOC and 90YDOTATOC (PRRT)

    Participants in this research study have tumors that express somatostatin receptors such as a neuroendocrine tumor, medulloblastoma, meningioma, and neuroblastoma. The purpose of this research study is to determine if 90Y-DOTATOC is an effective treatment for tumors that express somatostatin receptors and if 68Ga-DOTATOC PET/CT can measure the extent of disease and measure response to this therapy. This research will determine if this process called dosimetry is an effective technique to determine how much 90Y-DOTATOC the participants can safely receive without damage to their kidneys and bone marrow.

    August 20, 2020

  • Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors (GA-68)

    This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.

    August 20, 2020

  • Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

    This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.

    August 20, 2020
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University of Minnesota - Masonic Children's Hospital

University of Wisconsin - American Family Children's Hospital