Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma. SECONDARY OBJECTIVES: I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients. II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis. III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers. IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT. V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery. OUTLINE: Patients receive LET optimized IMPT for up to 6 weeks. After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03750513
Study type Interventional
Source M.D. Anderson Cancer Center
Contact David Grosshans
Phone 713-563-2300
Email dgrossha@mdanderson.org
Status Recruiting
Phase Phase 1
Start date April 1, 2019
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT00994071 - A Phase I Study of ABT-888, an Oral Inhibitor of Poly(ADP-ribose) Polymerase and Temozolomide in Children With Recurrent/Refractory CNS Tumors Phase 1
Completed NCT01171469 - Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor Phase 1
Completed NCT00520936 - A Study of Pemetrexed in Children With Recurrent Cancer Phase 2
Recruiting NCT04541082 - Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms Phase 1
Completed NCT02502708 - Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors Phase 1
Recruiting NCT04049669 - Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG Phase 2
Recruiting NCT06038760 - Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Active, not recruiting NCT03220035 - Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT03194906 - Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors Phase 2
Completed NCT03043391 - Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children Phase 1
Suspended NCT03095248 - Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors Phase 2
Active, not recruiting NCT02125786 - A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma Phase 2
Active, not recruiting NCT01096368 - Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma Phase 3
Terminated NCT01247922 - Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205 Phase 2
Completed NCT03900689 - Social Determinants of Health in Glioblastoma Population
Recruiting NCT04661384 - Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma Phase 1
Completed NCT03434262 - SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors Phase 1
Recruiting NCT05259605 - Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification
Terminated NCT01836549 - Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors Phase 2
Active, not recruiting NCT03638167 - EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors Phase 1