Primary Central Nervous System Lymphoma Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating
patients with primary central nervous system lymphoma.
OBJECTIVES:
- Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening primary central nervous system
lymphoma.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment
continues for at least 12 months in the absence of disease progression or unacceptable
toxicity. After 12 months, patients with responding or stable disease may continue
treatment.
Tumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months
for years 3 and 4, and then annually for years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04083066 -
Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma
|
Phase 4 | |
| Active, not recruiting |
NCT02313389 -
Maintenance Treatment Versus Observation in Elderly Patients With PCNS Lymphoma
|
Phase 3 | |
| Recruiting |
NCT02657785 -
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02836158 -
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06445257 -
A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL
|
N/A | |
| Recruiting |
NCT05135858 -
Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma
|
Phase 1 | |
| Completed |
NCT01421524 -
Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma
|
Phase 1 | |
| Active, not recruiting |
NCT00863460 -
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
|
Phase 2 | |
| Active, not recruiting |
NCT05036577 -
A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL
|
Phase 1 | |
| Recruiting |
NCT04514393 -
Ibrutinib With Methotrexate and Temozolomide for Patients With Newly Diagnosed Primary CNS Lymphoma
|
Phase 2 | |
| Not yet recruiting |
NCT04066920 -
IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL
|
Phase 2 | |
| Recruiting |
NCT03733327 -
BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT
|
Phase 2/Phase 3 | |
| Recruiting |
NCT00455286 -
a Phase II Study in Primary Central Nervous System Lymphoma
|
Phase 2 | |
| Completed |
NCT02301364 -
Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)
|
Phase 2 | |
| 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 |
NCT02669511 -
PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma
|
Phase 2 | |
| Not yet recruiting |
NCT04457869 -
A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)
|
Phase 2 | |
| Recruiting |
NCT02655744 -
Prospective Neurobehavioral Outcomes Follow-up in Primary CNS Lymphoma Patients Treated With Cranial Radiotherapy Combined With or Without MTX-based Chemotherapy According to the Multidisciplinary Treatment Guidelines Implemented at a Single Institute
|
||
| Recruiting |
NCT02399189 -
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04831658 -
A Prospective Clinical Study of BTK Inhibitor, PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma
|
Phase 1/Phase 2 |