Recurrent Childhood Medulloblastoma Clinical Trial
Official title:
Phase I Study of Intraventricular Infusions of Autologous Ex Vivo-Expanded NK Cells in Children With Recurrent/Refractory Malignant Posterior Fossa Tumors of the Central Nervous System. NOAH's (New Opportunity, Advancing Hope) Protocol
This phase I trial studies the side effects and best dose of expanded natural killer cells in treating younger patients with brain tumors that have come back or do not respond to treatment. Infusing a particular type of a patient's own white blood cells called natural killer cells that have been through a procedure to expand (increase) their numbers may work in treating patients with recurrent/refractory brain tumors.
PRIMARY OBJECTIVES:
I. To establish the safety, feasibility, efficacy, and maximum tolerated dose (MTD) of
administering autologous natural killer (NK) cells that have been propagated ex vivo with
artificial antigen-presenting cells (aAPC) and administered directly into the ventricle in
recurrent /refractory malignant posterior fossa tumors.
SECONDARY OBJECTIVES:
I. To assess the antitumor activity based on imaging and cytology of autologous NK cell
locoregional administration directly into the lateral or fourth ventricle.
II. To determine the persistence of adoptively-transferred expanded NK cells (as performed
with excess NK cells, via optional correlative studies).
III. Determine the immunophenotype and function of expanded NK cells. IV. Determine the
overall response of medulloblastoma to NK-cell therapy. V. Correlate NK cell persistence,
phenotype, and function with overall response.
OUTLINE: This is a dose-escalation study.
Patients receive autologous expanded NK cells intravenously (IV) into the ventricle over 3
minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 3 courses in the
absence of disease progression or unacceptable toxicity. Patients experiencing disease
progression may continue treatment at the discretion of the treating physician if
pseudo-progression or benefit of slowed progression is suspected.
After completion of study treatment, patients are followed up within 30 days.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02194452 -
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
|
N/A | |
Completed |
NCT00053963 -
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
|
Phase 1 | |
Completed |
NCT00095940 -
Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT00052780 -
Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors
|
Phase 1 | |
Completed |
NCT00004078 -
Irinotecan in Treating Children With Refractory Solid Tumors
|
Phase 2 | |
Completed |
NCT01239316 -
Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma
|
Phase 2 | |
Completed |
NCT00100880 -
Lenalidomide in Treating Young Patients With Recurrent, Progressive, or Refractory CNS Tumors
|
Phase 1 | |
Completed |
NCT00070525 -
Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma
|
Phase 2 | |
Terminated |
NCT01088763 -
Gamma-Secretase Inhibitor RO4929097 in Treating Young Patients With Relapsed or Refractory Solid Tumors, CNS Tumors, Lymphoma, or T-Cell Leukemia
|
Phase 1 | |
Completed |
NCT00326664 -
AZD2171 in Treating Young Patients With Recurrent, Progressive, or Refractory Primary CNS Tumors
|
Phase 1 | |
Completed |
NCT00101270 -
Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas
|
Phase 1 | |
Active, not recruiting |
NCT03210714 -
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Completed |
NCT02444546 -
Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors
|
Phase 1 | |
Completed |
NCT00363272 -
Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma
|
Phase 1 | |
Completed |
NCT00946335 -
ABT-888 and Temozolomide in Treating Young Patients With Recurrent or Refractory CNS Tumors
|
Phase 1 | |
Completed |
NCT00063973 -
Cilengitide in Treating Children With Refractory Primary Brain Tumors
|
Phase 1 | |
Completed |
NCT00822458 -
GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment
|
Phase 1 | |
Active, not recruiting |
NCT00638898 -
Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor
|
Phase 1 | |
Terminated |
NCT02684071 -
Phase II Study of Intraventricular Methotrexate in Children With Recurrent or Progressive Malignant Brain Tumors
|
Phase 2 | |
Completed |
NCT01076530 -
Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors
|
Phase 1 |