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With a modest target volume increase to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach, as early evidence of the outcome is ineffective, the PFS should be monitored for early signs that the result is misleading. With a modest target volume increase to the tumor bed and reduced chemotherapy, we can prospectively assess and longitudinally model the cognitive, socioeconomic, emotional, socioeconomic, emotional, and quality of life of children treated with reduced CSI. According to the Heidelberg classification system, researchers will determine whether DNA methylation profiling of medulloblastoma samples would result in a predictive classification scheme for the Sonic Hedgehog, Group 3, and Group 4 medulloblastoma subgroups. With a limited target volume boost to the tumor bed and reduced cisplatin and vincristine chemotherapy, we will discuss the audiologic and endocrinologic dysfunctions, as well as peripheral neuropathy in children treated with reduced CSI. OUTLINE: RADIATION THERAPY: Patients are undergoing craniospinal radiation therapy for 5 days a week for six weeks after surgery, starting 4-5 weeks after surgery. Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8.
Source link: https://clinicaltrials.gov/ct2/show/NCT02724579
Primary Objectives This research seeks to determine the progression free survival of SHH-2 infant and young child medulloblastoma patients treated with systemic HD-MTX-based chemotherapy alone. To patients treated with systemic chemotherapy and intra-ventricular chemotherapy or delayed risk-adapted craniospinal irradiation, we can compare cognitive outcomes among infants and young children treated with systemic chemotherapy alone to those treated with systemic chemotherapy and intra-ventricular chemotherapy or delayed risk-adapted craniospinal irradiation. To determine the degree of intra- and intra-patient methotrexate dose variation in ventricular CSF infants with medulloblastoma, and to investigate correlations between methotrexate CSF pharmacokinetics and clinical effects, click here. Stratum S-2: Patients on S-2 will be offered 8 courses of chemotherapy, consisting of: 4 Course A 2 Course B2 Course B 2 Week B 2 Course C Courses repeats every 28 days/4 weeks. Patients on S-1 will be treated with the same systemic chemotherapy regimen as S-2, but with the addition of intraventricular MTX, administered via Ommaya reservoir, and each systemic MTX infusion. There is no established maximum number of systemic chemotherapy courses in stratum N. The length of chemotherapy will vary depending on the patient's age at enrollment. Patients who are stratum N patients reach 36 months of age, whether stratum N patients achieve 36 months of age, or N-3 will be re-stratified onto substratum N-1, N-2, or N-3 based on their chemotherapy response. After completing CSI, patients enrolled in stratum N who have only received two courses of pre-radiation chemotherapy will be given two additional courses of adjuvant chemotherapy.
Source link: https://clinicaltrials.gov/ct2/show/NCT05535166
As per the Children's Oncology Group's trial, patients with chronic medulloblastoma will have surgery before study entry, followed by Induction Chemotherapy with irinotecan, temozolomide, and bevacizumab as per the Children's Oncology Group's trial ACNS0821. Patients may go back to Radioimmunotherapy after 2 or four courses of chemotherapy, and if radiographic disease status is stable or improved, patients can go to Radioimmunotherapy to receive 2 therapeutic doses of cRIT 131I-omburtamab. The medulloblastoma cohort treated on ACNS0821 on the irinotecan + temozolomide + bevacizumab arm will be the primary comparison for this study. Patients will enroll on Stratum 2 and receive one dosimetry dose of nuclear medicine scintigraphy using SPECT during the Dosimetry Course if positive, according to SPECT. Patients can continue to Radioimmunotherapy after the Dosimetry Course and within two weeks of the dosimetry dose, receiving two therapeutic doses of cRIT 131I-omburtamab.
Source link: https://clinicaltrials.gov/ct2/show/NCT04743661
Patients with relapsed medulloblastoma, ependymoma, and ATRT have a poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation, or combinations of these techniques. Solid malignancies have the use of antiangiogenetic therapy. The investigators will explore the use of biweekly intravenous bevacizumab in combination with five oral medications, augmented by alternating courses of intrathecal etoposide and cytarabine in this review. The primary aim of the MEMMAT trial is to determine the effectiveness of this multidrug antiangiogenic therapy in these heavily treated children and young adults.
Source link: https://clinicaltrials.gov/ct2/show/NCT01356290
Metformin was safe and tolerable for use in children/adolescents treated with cranial radiation for a brain tumor and can enhance cognition and promote white matter growth, according to a pilot trial with 24 participants. We will investigate the efficacy of metformin therapy for brain repair and cognitive recovery in medulloblastoma patients in this multi-site clinical trial. If we find that metformin promotes cognitive development and brain growth in paediatric survivors of medulloblastoma, this could be a cost-effective therapeutic strategy that may increase the quality of life of these cancer patients and provide a model for treating late effects in other paediatric cancers. We speculate that 16 weeks of metformin therapy will result in improved cognitive outcomes than 16 weeks of placebo therapy. We hypothesize that 16 weeks of metformin therapy will be associated with increased white matter growth in the corpus callosum compared to 16 weeks of placebo therapy. At Post-Intervention compared to Baseline, we hypothesize that 16 weeks of metformin therapy will stimulate global white matter increase in the brain. Based on the results of 16 weeks of anti-intervention with metformin at Post-Intervention, we predict that 16 weeks of metformin treatment will result in greater hippocampal volume increases in hippocampal volume, relative to those with placebo at Baseline.
Source link: https://clinicaltrials.gov/ct2/show/NCT05230758
SurvivaxM in pediatric patients has no published clinical trials; however, SurvivaxM has been tested in a number of adult studies, including a phase I analysis at Roswell Park Comprehensive Cancer Center. As an add-on to standard chemotherapy, the priming phase of vaccination was followed by the introduction of standard adjuvant chemotherapy with temozolomide and maintenance doses of SurvivaxM. Both of whom recovered were grade 1-2 injection site reactions in two patients with Montanide-related panniculitis with local skin ulceration at vaccination injection sites, the most common AE was grade 1-2 injection site reaction. If successful, a controlled phase IIb clinical trial of standard therapy plus SurvivaxM is currently underway, with the intention of drug testing if successful. This trial was conducted to determine SurvivaxM's toxicity profile in children with relapsed or progressive medulloblastoma and high-grade glioma, ependyma, and non-recurrent diffuse intrinsic pontine glioma post-radiation therapy. Through a second subcutaneous injection in close proximity to the vaccine injection site, the SurvivaxM-Montanide injection will be followed immediately by sargramostim or biosimilar. A maintenance dose of SurvivaxM with Montanide ISA 51 may be administered every eight weeks until an off-treatment target is achieved, beginning 8 weeks after the fourth priming dose.
Source link: https://clinicaltrials.gov/ct2/show/NCT04978727
In each stratum separately, the adult recommended dose of peronizumab will be used to establish the safety and identify adverse effects. To establish the safety and reporting of adverse effects associated with the administration of the adult approved dose of pemorabilizumab in pediatric patients with progressive or recurrent hypermutated tumors, as well as those with constitutional mismatch deficiency syndrome. To determine changes in the PD-1hi CD8+ T cell collection from serial peripheral blood samples collected before and after chemotherapy with pembrolizumab, including those with CMMRD syndrome, patients with hypermutated brain tumors, V. To determine changes in the immunophenotypic profile of PD-1hi CD8+ T cells from serial peripheral blood samples obtained prior to and during pessimist brain tumors in pediatric patients with accelerated brain tumors, including those with CMMRD syndrome To determine the duration of objective response in patients with measurable disease at baseline and estimate progression-free/overall survival for patients in each stratum treated with peguolizumab, see table below. V. To determine whether elevated relative cerebral blood volume and transfer coefficient can distinguish pseudoprogress/tumor inflammation in tumors treated on this regimen, we'll explore the use of serial MR permeability and MR perfusion to determine if elevated relative cerebral blood volume and transfer coefficient can tell the difference between pseudoprogression/tumor inflammation from tumor progression in tumors treated on this regimen. To determine the progression-free survival of all patients with elevated progressive low grade gliomas, including those with CMMRD treated with pesozumab. T-cell receptor repertoire in PD-1+ cells obtained from peripheral blood or tumor tissue, if available, should be categorized by the T-cell receptor gene complex, before and after therapy with pemolizumab in pediatric patients treated in stratum C. Objective IX: To determine the specificity of T-cell receptors against tumor antigens isolated in objective IX.
Source link: https://clinicaltrials.gov/ct2/show/NCT02359565
With recurrent SHH medulloblastoma II, it was determined that the maximum tolerated dose and/or the recommended phase II dose of CX-4945 should be administered orally daily to skeletally-immature children with recurrent SHH medulloblastoma II. With recurrent SHH medulloblastoma, we'll review the pharmacokinetics of CX-4945, which was administered orally daily to skeletally-immature children with recurrent SHH medulloblastoma. Following the administration of CX-4945 and surgical resection, we can determine the tumor concentrations in CX-4945. To determine the effectiveness and characterization of 1000 mg BID continuous dosing of CX-4945 in skeletally-mature patients with recurrent SHH medulloblastoma, click here. I. To determine the objective response rate associated with CX-4945 in skeletally-mature patients with recurrent SHH medulloblastoma. SECONDARY OBJECTIVES: I. With recurrent SHH medulloblastoma, To announce preliminary antitumor activity of CX-4945 in skeletally-immature children with recurrent SHH medulloblastoma. Within the confines of a Phase I research, a genetic analysis can be performed to determine correlation between reaction to therapy and the presence of specific genomic abnormalities. After the first three patients in the skeletally-mature cohort are monitored for initial safety monitoring and did not experience excessive toxicity, the surgical study will be conducted. As soon as the surgical study is started and the BSA adjusted equivalent with 1000 mg BID or its BSA adjusted equivalent depending on age and BSA, subjects with recurrent or refractory SHH medulloblastoma will be eligible. Participants in the Phase 1 trial will only be eligible to enroll in the surgical trial after the MTD is defined in the Phase 1 component and will receive drugs at the established MTD for this cohort.
Source link: https://clinicaltrials.gov/ct2/show/NCT03904862
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