Ependymoma Clinical Trial
Official title:
Phase I Study of 5-Fluorouracil in Children and Young Adults With Recurrent Ependymoma
This is a phase I study to investigate the safety and pharmacokinetics of weekly 5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with recurrent or refractory ependymoma. The results from this study will inform a subsequent phase II St. Jude investigator-initiated trial.
The initial 5-FU dosage will be 500 mg/m^2 administered on day 1 of course 1. We plan to
treat a maximum of 3 cohorts of research participants (dosage levels - 0, 1, and 2) with
escalating doses of 5-FU. A cycle is defined as 42 days. The first 6 weeks of therapy will
constitute the dose-limiting toxicity (DLT) evaluation period.
Primary objective
- To investigate the safety and pharmacokinetics (plasma and cerebrospinal fluid) of
weekly bolus dose 5-FU in children and young adults with recurrent/refractory
ependymoma
- To study the safety of 500 mg/m^2 weekly bolus dose 5-FU in less-heavily pre-treated
children and young adults with recurrent/refractory ependymoma.
Secondary objectives
- To document and describe toxicities associated with 5-FU administered on a weekly bolus
schedule
- To document preliminary antitumor activity in participants with recurrent or refractory
ependymoma treated with 5-FU
- To assess the feasibility of measuring expression level of Thymidylate Synthetase
(TYMS) in formalin fixed paraffin embedded (FFPE) tumor samples using the Quantigene
assay
- To evaluate the association between specific genetic polymorphisms (e.g., DPYD) and the
pharmacokinetics of 5-FU
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 | |
| Active, not recruiting |
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 |