Pediatric Brain Tumor Clinical Trials

Showing 1-13 of 13 items
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  • Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma
  • This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
  • Diagnoses: Pediatric Oncology, Pediatric Brain Tumor
  • Status: Recruiting
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  • Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
  • The primary objective of this study is to estimate the overall survival of children and young adults with diffuse intrinsic pontine glioma treated (DIPG) with a molecularly based treatment strategy, compared to historical controls. Four Biopsies of tumor tissue will be obtained by surgical biopsy prior to treatment stratification if tolerated. An MRI-guided frameless or frame-based stereotactic biopsy will be performed approaching the pontine termentum through a trans-cerebellar or trans-frontal route. The exact biopsy location will be determined by the treating neurosurgeon at the designated participating site with the goal of minimizing procedural risk. Following biopsy,all patients will receive local radiotherapy to consist of 59.4Gy delivered using conventional conformal or other standard treatment planning with adjuvant bevacizumab. Radiation planning can begin with the pre-operative images. Based upon molecular parameters after biopsy, patients will potentially receive erlotinib and/or temozolomide at the start of radiotherapy. Bevacizumab will be given concurrently with radiotherapy beginning at least three weeks from the biopsy and at least two weeks after the start of radiation therapy to ensure that primary wound healing has occurred. Once irradiation is complete, patients will have a four week interim period before beginning the maintenance phase. Adjuvant chemotherapy will be continued during the interim period. The maintenance phase (approxmiately 40 weeks) will last for 10 cycles(28 days +/- 3 days). Based upon molecular parameters as determined at the time of diagnostic biopsy, patients will continue to receive erlotinib and/or temozolomide along with bevacizumab during the maintenance phase. Stratification will be based on O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status and epidermal growth factor receptor (EGFR) expression in tumor biopsy samples. If MGMT status and/or EFGR status are not determinable, patients may be treated as per cohort #1(bevacizumab and irradiation) but will be analyzed separately.
  • Diagnoses: Pediatric Brain Tumor
  • Status: Recruiting
4.
  • Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation
  • Some patients with brain tumors receive standard radiation to help prevent tumor growth. Although standard radiation kills tumor cells, it can also damage normal tissue in the process and lead to more side effects. This research study is looking at a different form of radiation called proton radiotherapy which helps spare normal tissues while delivering radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue then standard radiation. This therapy has been used in treatment of other cancers and information from those other research studies suggests that this therapy may help better target brain tumors then standard radiation.
  • Diagnoses: Pediatric Brain Tumor
  • Status: Recruiting
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  • MEK Inhibitor PD-0325901 Trial in Adolescents and Adults With NF1
  • This phase II open label study will evaluate adolescents (≥ 16 years of age) and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with the MEK inhibitor PD-0325901. The primary aim of the study will be to assess quantitative radiographic response in a target lesion. Subjects will receive PD-0325901 by mouth on a bid dosing schedule of 2 mg/m2/dose with a maximum dose of 4 mg bid. Each course is 4 weeks duration, and subjects will receive drug on a 3 week on/1 week off schedule. Subjects may receive additional courses beyond course 8 only if there is at least 15% reduction in volume of the target tumor. Subjects who have a 20% or greater reduction in target tumor volume at the end of 12 courses can continue on therapy for up to an additional year (maximum of 24 total courses). However, subjects who do not achieve at least 15% reduction in volume of the target tumor after 8 courses (~8 months) will be considered treatment failures and taken off study. The Primary purpose of this protocol is to determine whether PD-0325901 results in objective radiographic responses based on volumetric MRI measurements in adolescents and adults with NF1 and growing or symptomatic inoperable PN. There are several secondary aims of this protocol: To evaluate the feasibility and toxicity of chronic PD-0325901 administration in this patient population To estimate the objective response rate of up to 2 non-target plexiform neurofibromas to PD-0325901by MRI To characterize the pharmacokinetic profile of PD-0325901 when administered to this patient population To characterize the pharmacodynamic profile of PD-0325901 when administered to this patient population using dermal neurofibromas as a surrogate for plexiform neurofibroma cells To characterize the activity of PD-0325901 on neurofibroma cell gene expression To characterize the activity of PD-0325901 on plasma cytokines and growth factors To correlate pERK levels to pharmacokinetic data and response To evaluate quality of life and pain during treatment with PD-0325901 To validate the PedsQL NF1 QOL Module, a disease specific QOL scale, for use in this patient population, and To determine whether subjects who respond (≥20% objective radiographic response of target lesion by 12 courses) to PD-0325901 will maintain that response for 1 year one they come off therapy
  • Diagnoses: Pediatric Brain Tumor
  • Status: Recruiting
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  • Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
  • This pilot clinical trial studies whether unilateral group D retinoblastoma, or retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can be treated with a new technique for delivering chemotherapy directly into the blood vessel that supplies the affected eye. This new technique is called intra-arterial injection. This may give children with unilateral retinoblastoma a lower chance of needing surgery to remove the eye and reduce the amount of treatment side effects.
  • Diagnoses: Pediatric Brain Tumor
  • Status: Recruiting
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  • Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
  • Primary Objective: - To determine the maximum tolerated dose (MTD) of cabazitaxel as a single agent in pediatric patients with recurrent or refractory solid tumors including tumors of the central nervous system. Secondary Objectives: - To characterize the safety and tolerability of cabazitaxel in pediatric patients with recurrent or refractory solid tumors including tumors of the central nervous system. - To characterize the pharmacokinetic (PK) profile of cabazitaxel in pediatric patients with recurrent or refractory solid tumors including tumors of the central nervous system. - To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in pediatric patients with recurrent or refractory solid tumors including tumors of the central nervous system.
  • Diagnoses: Pediatric Brain Tumor, Pediatric Solid Tumors
  • Status: Recruiting
12.
  • The Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Pediatric Subjects
  • This is a 2-part, study to determine the safety, tolerability and pharmacokinetics of oral dabrafenib in pediatric subjects with advanced BRAF V600 mutation-positive solid tumors. Part 1 (dose escalation study) will identify the recommended Part 2 (tumor-specific expansion study) dose and regimen using a dose-escalation procedure. Approximately 6 to 18 subjects will participate in Part 1 and will receive a starting dose of 3 mg/kg and dose will deescalate or escalate between 1.5 milligram (mg)/kilogram (kg) and 4.5 mg/kg. Up to 6 subjects will be enrolled at one dose level dependent upon the number of subjects at the current dose level, the number of subjects who have experienced a dose limiting toxicity (DLT) at the current dose level, and the number of subjects enrolled but with data pending at the current dose level. Escalation may proceed until either a maximum tolerated dose (MTD) is established, or until the dose in which the median pharmacokinetic parameters consistent with exposure in adults are achieved. Cohorts may be added in order to evaluate additional dose levels. Part 2 consists of four disease-specific cohorts of subjects with tumors known to have BRAF V600 activation (pediatric low-grade gliomas, pediatric high-grade gliomas, Langerhans cell histiocytosis [LCH], and other tumors such as melanoma and papillary thyroid carcinoma [PTC]). Each cohort will enroll at least 10 subjects with a pre-dose and at least 1 post-dose disease assessment. In both the parts of the study, on Day 1, a single first dose will be administered, and repeat dosing will begin on Day 2. PK sampling will be performed on Day 1 and Day 15 for subjects >=25 kg in weight. For subjects <25 kg in weight, blood samples for PK analysis will be collected after repeated administration on Day 15 only. Safety and tolerability will be assessed throughout the study. Treatment with dabrafenib will be continued until disease progression or until no clinical benefit or development of an unacceptable toxicity, or until they withdraw consent or begin a new therapy. At the end of treatment, a final study visit will occur.
  • Diagnoses: Pediatric Solid Tumors, Pediatric Brain Tumor
  • Status: Recruiting
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