Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma

Status Completed

Clinical Trial Summary

The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

Clinical Trial Description

Recurrent glial tumors of the brain continue to be one of the most challenging malignancies to treat. Median survival for patients with recurrent disease is approximately 6 months for glioblastoma multiforme. Bevacizumab is used for treatment of recurrent disease; however patients who fail bevacizumab do not have many treatment options.

Metastases to the brain are the most common intracranial tumors in adults and occur ten times more frequently than primary brain tumors. It is estimated that 8 - 10% of cancer patients may develop symptomatic metastatic tumors in the brain. Systemic therapy is rarely used for primary treatment of brain metastases because many tumors that metastasize to the brain are not chemosensitive or have been already heavily pretreated with potentially effective agents, and poor penetration through the blood brain barrier is an additional concern.

Dianhydrogalactitol (DAG) rapidly penetrates both the cerebrospinal fluid (CSF) and the blood-brain barrier and accumulates in brain tissue. Clinical study of DAG in patients with GBM or with progressive secondary brain tumors is warranted. Patients with secondary brain metastases were allowed to enroll into the current protocol in Cohorts 2 and 3; however, enrollment ceased with Amendment 5 and will not be continued beyond Cohort 3.

This study will utilize a standard 3 + 3 dose escalation design, until the MTD or the maximum specified dose has been reached. In Phase 2, additional patients with GBM will be treated at the MTD (or other selected optimum Phase 2 dose) to measure tumor responses to treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01478178
Study type	Interventional
Source	DelMar Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	October 2011
Completion date	October 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05664243` - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT02768389` - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma	Early Phase 1
Recruiting	`NCT05635734` - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT03679754` - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102	Phase 1
Completed	`NCT01250470` - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma	Phase 1
Terminated	`NCT03927222` - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma	Phase 2
Recruiting	`NCT03897491` - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma	Phase 2
Active, not recruiting	`NCT03587038` - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma	Phase 1
Completed	`NCT01922076` - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas	Phase 1
Recruiting	`NCT04391062` - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma	Phase 2
Active, not recruiting	`NCT03661723` - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma	Phase 2
Active, not recruiting	`NCT02655601` - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001	Phase 2
Completed	`NCT02206230` - Trial of Hypofractionated Radiation Therapy for Glioblastoma	Phase 2
Completed	`NCT03493932` - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade	Phase 1
Terminated	`NCT02709889` - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06058988` - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer	Phase 2
Completed	`NCT03018288` - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)	Phase 2
Not yet recruiting	`NCT04552977` - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	Phase 2
Withdrawn	`NCT03980249` - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells	Early Phase 1
Terminated	`NCT02905643` - Discerning Pseudoprogression vs True Tumor Growth in GBMs