Anaplastic Oligodendroglioma Clinical Trial
Official title:
Phase I/II Study of Carboplatin, Melphalan and Etoposide Phosphate in Conjunction With Osmotic Opening of the Blood-Brain Barrier and Delayed Intravenous Sodium Thiosulfate Chemoprotection, in Previously Treated Subjects With Anaplastic Oligodendroglioma or Oligoastrocytoma
This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.
PRIMARY OBJECTIVES: I. To evaluate toxicity and estimate the maximum tolerated dose (MTD) of melphalan (intra-arterially [i.a.]) administered in conjunction with carboplatin (i.a.) and etoposide phosphate (intravenously [i.v.]) undergoing BBBD, in subjects with anaplastic oligodendroglioma or oligoastrocytoma. (Phase I) II. To examine the efficacy (one year progression free survival [1YPFS]) of carboplatin (i.a.), melphalan (i.a.) and etoposide phosphate (i.v.) in conjunction with BBBD, in subjects with anaplastic oligodendroglioma or oligoastrocytoma. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the incidence of severe neutropenia (specifically febrile neutropenia or sepsis) of carboplatin (i.a.), melphalan (i.a.) and etoposide phosphate (i.v.) in conjunction with BBBD, in subjects with anaplastic oligodendroglioma or oligoastrocytoma. II. To evaluate the overall toxicity of carboplatin (i.a.), melphalan (i.a.), and etoposide phosphate (i.v.) in conjunction with BBBD. III. To estimate the differences in tumor response, 1YPFS and survival, in subjects with allelic loss of chromosomes 1p and 19q, and tumor protein p53 (p53) immunocytochemistry, versus subjects without allelic loss. IV. To assess quality of life, cognitive function, and performance status of subjects undergoing treatment with carboplatin, melphalan and etoposide phosphate in conjunction with BBBD. V. To estimate differences in 1YPFS between subjects with anaplastic oligodendroglioma and patients with oligoastrocytoma. VI. To describe the role of biopsy versus extent of surgery (sub-maximal versus maximal safe resection) on 1YPFS and survival. VII. To describe the role of prior radiation on tumor response, 1YPFS and survival. OUTLINE: This is a phase I, dose-escalation study of melphalan followed by a phase II study. Patients receive etoposide phosphate IV over 10 minutes, mannitol IA over 30 seconds, melphalan IA over 10 minutes, and carboplatin IA over 10 minutes on days 1 and 2. Patients then receive sodium thiosulfate IV over 15 minutes at 4 and 8 hours after carboplatin. Courses repeat every 4 to 6 weeks for up to 12 months. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
| Active, not recruiting |
NCT00995007 -
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
|
Phase 2 | |
| Recruiting |
NCT04541082 -
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
|
Phase 1 | |
| Completed |
NCT00390299 -
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT03043391 -
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
|
Phase 1 | |
| Recruiting |
NCT03975829 -
Pediatric Long-Term Follow-up and Rollover Study
|
Phase 4 | |
| Completed |
NCT02644291 -
Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT01847235 -
Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial
|
Phase 2 | |
| Completed |
NCT01380782 -
BIBF 1120 for Recurrent High-Grade Gliomas
|
Phase 2 | |
| Completed |
NCT01082926 -
Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2
|
Phase 1 | |
| Completed |
NCT00362570 -
Temozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma
|
Phase 2 | |
| Active, not recruiting |
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 | |
| Completed |
NCT01316809 -
AZD8055 for Adults With Recurrent Gliomas
|
Phase 1 | |
| Recruiting |
NCT04135807 -
Implantable Microdevice In Primary Brain Tumors
|
Early Phase 1 | |
| Completed |
NCT01522820 -
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
|
Phase 1 | |
| Completed |
NCT00884416 -
Sorafenib in Newly Diagnosed High Grade Glioma
|
Phase 1 | |
| Active, not recruiting |
NCT02101905 -
Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma
|
Phase 1 | |
| Recruiting |
NCT05698524 -
A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
|
Phase 1 | |
| Recruiting |
NCT01637753 -
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
|
N/A | |
| Withdrawn |
NCT00734864 -
Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma
|
Phase 1 |