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Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically...
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Immunotherapy for Recurrent Ependymomas in Children Using Tumor Antigen Peptides with Imiquimod
The purpose of this study is to see if vaccination with HLA-A2 restricted peptides, combined with the immunoadjuvant imiquimod is safe and can induce immune responses in children with recurrent ependymomas. Eligible patients are stratified by primary tumor location.
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Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
This phase II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and ipilimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and ipilimumab in combination with sirolimus and prednisone may kill more cancer...
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Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer
The primary objective of the study is to assess the efficacy in terms of CNS-specific PFS of the combination of standard systemic treatment plus SRS vs. standard systemic treatment alone in patients with newly diagnosed and untreated (except for surgery) asymptomatic or oligosymptomatic brain metastases from melanoma or NSCLC. This proposed randomised phase III clinical study addresses one of the most controversial issues in the current approach to patients with brain mets: the timing of SRS in patients eligible for systemic immune checkpoint inhibition or targeted therapy in order to guide therapeutic options as to what strategy allows the best compromise between best survival and...
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Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme
Rationale of the Study: Treatment for GBM currently consists of surgical resection of the tumour mass followed by radio- and chemotherapy ((1)Stupp et al., 2005). Nonetheless overall prognosis still remains bleak, recurrence is universal, and recurrent GBM patients clearly need innovative therapies. Dendritic cells (DC) immunotherapy could represent a well-tolerated, long-term tumour-specific treatment to kill all (residual) tumour cells which infiltrate in the adjacent areas of the brain. Preclinical investigations for the development of therapeutic vaccines against high grade gliomas, based on the use of DC loaded with a mixture of glioma-derived tumor have been carried out in...
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Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
Management of melanoma is based on primary excision of the tumor. In cases of melanoma with poor prognosis criteria, or when it is locally advanced or metastatic, there is an indication for the implementation of adjuvant therapy, which may, in this context, be immunotherapy. Immunotherapies are treatments that have revolutionized the prognosis of patients with melanoma. These are therapies that work by stimulating the immune system to enhance the anti-tumor response. Their toxicities are represented by immune-mediated toxicities, similar to true autoimmune diseases. Adapted physical activity as supportive care in oncology is expanding. From a pathophysiological perspective,...
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Impact of Salovum® and SPC® Flakes on Brain Tumor Induced Edema
The objective of this clinical trial is to explore the effects of Salovum®, an egg yolk powder enriched with the endogenous protein antisecretory factor, and SPC® flakes , hydrothermically processed oats, on cerebral edema with clinical symptoms in participants with brain tumors. The primary questions the trial seeks to answer are: - Can Salovum® and SPC® flakes have effect on clinical symptoms of tumor-induced cerebral edema? - Can Salovum® and SPC® flakes induce regression of radiological edema in tumor-induced cerebral edema Additionally, the study will investigate the impact of Salovum® and SPC® flakes in steroid refractory, steroid naïve cerebral...
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Impact of Telemonitoring for the Management of Side Effects in Patients with Melanoma, Lung or Renal Cancer, Treated with Immunotherapy Combination of Nivolumab and Ipilimumab or Adjuvant Nivolumab Monotherapy
The ipilimumab and nivolumab combination is now part of the standard of care for the treatment of melanoma, renal and lung cancer patients. Grade 3/4 adverse events (AEs) occur in 30 to 60% of patients included in clinical trials. Grade 3/4 AEs are more frequently observed (50-60% of patients) in melanoma because ipilimumab is administrated at 3mg/kg in this population. Among these AEs, early detection of immune related AEs is critical to an adequate medical management. In this context, dedicated tools for remote monitoring of these patients are crucial. The investigators developed within the Immucare consortium a simplified medical questionnaire which is addressed weekly to the...
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Impact of the Development of Pediatric Palliative Care
Despite medical advances, cancer remains the leading cause of death by disease in children. Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers. The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor. The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals. Over the last decade, the concept of palliative care has...
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Implantable Microdevice In Primary Brain Tumors
This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. - The device involved in this study is called a microdevice. - The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.
