Malignant Glioma Clinical Trial
Official title:
A Pilot Study of Allogeneic Hematopoietic Cell Transplantation for Patients With High Grade Central Nervous System Malignancies
This phase I trial investigates the side effects and effectiveness of chemotherapy followed by a donor (allogeneic) stem cell transplant when given to patients with high grade brain cancer. Chemotherapy drugs, such as fludarabine, thiotepa, etoposide, melphalan, and rabbit anti-thymocyte globulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.
PRIMARY OBJECTIVE: I. To assess tolerability of allogenic hematopoietic cell transplantation (HCT) among patients with chemo-responsive high-grade central nervous system (CNS) malignancies as defined by transplant-related mortality (TRM) at day 30 as well as rate of grade III organ toxicity or higher (Bearman Regimen-Related Toxicities Scale) attributable to conditioning occurring within 30 days. SECONDARY OBJECTIVES: I. Median time to platelet and neutrophil engraftment. II. Incidence of acute graft-versus-host disease (aGVHD) by day 100. III. Incidence of chronic GVHD at day 100 and one year. IV. Rate of grade II organ toxicity through day 100. V. Rate of graft failure (primary and secondary) through day 100. VI. Rate of infectious complications through day 100. VII. Progression free survival at day 180. VIII. Cumulative incidence of relapse, overall survival, and progression-free survival at 100 days and 1 year. OUTLINE: Patients receive thiotepa intravenously (IV) over 2-4 hours and etoposide IV over 60 minutes on days -8 to -6, melphalan IV over 20 minutes on days -5 and -4, and fludarabine phosphate IV over 1 hour on days -5 to -3. Patients receiving umbilical cord transplant only also receive lapine T-lymphocyte immune globulin IV over 4-12 hours on days -4 and -3. Patients then undergo HCT on day 0. Patients also receive tacrolimus IV or cyclosporine IV beginning on day -2 to and mycophenolate mofetil orally (PO) every 8 hours or IV from days 0-40 and tapered to day 90. After completion of study treatment, patients are followed up at 100, 180, 270 and 360 days. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02764151 -
First in Patient Study for PF-06840003 in Malignant Gliomas
|
Phase 1 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Completed |
NCT00953121 -
Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)
|
Phase 2 | |
Completed |
NCT00766467 -
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
|
Phase 2 | |
Active, not recruiting |
NCT03233204 -
Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
Recruiting |
NCT05045027 -
Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma
|
Early Phase 1 | |
Completed |
NCT02507583 -
Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma
|
Phase 1 | |
Completed |
NCT04109209 -
Psychological Intervention For Brain Tumor Caregivers
|
N/A | |
Recruiting |
NCT04937413 -
The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation
|
Early Phase 1 | |
Completed |
NCT03615404 -
Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma
|
Phase 1 | |
Active, not recruiting |
NCT04175301 -
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
|
Phase 2 | |
Terminated |
NCT02659800 -
Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas
|
Phase 1 | |
Active, not recruiting |
NCT02323880 -
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
|
Phase 1 | |
Completed |
NCT00782756 -
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
|
Phase 2 | |
Terminated |
NCT02855086 -
Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT02861222 -
Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma
|
Phase 1 | |
Completed |
NCT00634231 -
A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors
|
Phase 1 | |
Completed |
NCT01792505 -
Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
|
Phase 1 | |
Completed |
NCT00190723 -
A Study of LY317615 in Patients With Brain Tumors
|
Phase 2 | |
Recruiting |
NCT04323046 -
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
|
Phase 1 |