Intraocular Lymphoma Clinical Trial
Official title:
Phase I Study of Intraventricular Administration of Rituximab in Combination With Methotrexate in the Treatment of Recurrent CNS and Intraocular Lymphoma
Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer
and has been proven to lead to extended survival when administered intravenously in the
treatment of patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated
that a small fraction of Rituximab administered intravenously is able to cross the
blood-brain-barrier into the brain.
We will test the idea that the direct injection into the cerebrospinal fluid of Rituximab, a
monoclonal antibody which attacks and kills lymphoma cells, is safe and when used in
combination with methotrexate in patients with recurrent brain and intraocular lymphoma.
We will also test the idea that the combination of rituximab plus methotrexate has activity
and is effective in the treatment of recurrent brain and intraocular lymphoma.
Rituximab is the first monoclonal antibody to receive FDA approval in the treatment of
cancer. Intravenous administration of rituximab has been demonstrated to lead to
prolongation of survival when used in combination with chemotherapy in the treatment of
patients with systemic non-Hodgkin's lymphoma. We have previously demonstrated that a small
fraction of Rituximab administered intravenously is able to cross the blood-brain-barrier
into the brain and we have also previously demonstrated that direct intraventricular
administration of Rituximab is able to achieve high concentrations within the cerebrospinal
fluid ventricles and lumbar sac.
We will test the hypothesis that the direct intraventricular injection of Rituximab in
combination with Methotrexate is safe and when used in combination in patients with
recurrent brain and intraocular lymphoma. We will evaluate the safety of this combination by
testing different dose levels of Rituximab. We will also measure the concentration of
Rituximab in the intraocular compartments and cerebrospinal fluid at different time points
after intraventricular administration to determine the pharmacokinetics of intrathecal
Rituximab as well as the potential impact of Methotrexate on Rituximab distribution.
We will also test the hypothesis that the intraventricular administration of the combination
of rituximab plus methotrexate has activity and is effective in the treatment of recurrent
brain and intraocular lymphoma.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02542514 -
Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma
|
Phase 2 | |
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
| Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT01815749 -
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT02281279 -
Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00608361 -
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
| Completed |
NCT00098891 -
MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00004241 -
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
|
Phase 1 | |
| Completed |
NCT01254578 -
Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers
|
Phase 1 | |
| Completed |
NCT01748721 -
MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
|
Phase 1 | |
| Terminated |
NCT00101205 -
Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
|
Phase 1 | |
| Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A | |
| Completed |
NCT01129193 -
AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukemia, or Lymphoma
|
Phase 1 | |
| Terminated |
NCT01419795 -
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01658319 -
Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
| Terminated |
NCT01116154 -
Vorinostat and Lenalidomide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
|
Phase 1 | |
| Completed |
NCT00458731 -
Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma
|
Phase 1 | |
| Terminated |
NCT00354185 -
PXD101 and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma
|
Phase 1 |