HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Status Recruiting

Clinical Trial Summary

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.

Clinical Trial Description

This is a prospective phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy in recurrent glioblastoma multiforme or anaplastic astrocytoma. This study is comprised of patients who have failed standard of care treatment (maximal safe resection followed by chemoradiation). Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination wherever a re-operation is clinically indicated. Blood samples will be taken for systemic immunological response, blood counts and liver functions tests. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores. Patients will also be followed to assess median time to progression and median survival. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03596086
Study type	Interventional
Source	The Methodist Hospital Research Institute
Contact	David S Baskin, MD
Phone	713-441-3803 or 713-201-5792
Email	DBaskin@houstonmethodist.org
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	December 11, 2017
Completion date	December 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05023551` - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma	Early Phase 1
Recruiting	`NCT06059690` - Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells	Phase 1/Phase 2
Recruiting	`NCT04116411` - A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients	Phase 2
Terminated	`NCT01902771` - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors	Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT02386826` - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme	Phase 1
Completed	`NCT00038493` - Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme	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
Recruiting	`NCT01923922` - CT Perfusion in the Prognostication of Cerebral High Grade Glioma	N/A
Completed	`NCT01956734` - Virus DNX2401 and Temozolomide in Recurrent Glioblastoma	Phase 1
Completed	`NCT01402063` - PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation	Phase 2
Completed	`NCT01301430` - Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.	Phase 1/Phase 2
Suspended	`NCT01386710` - Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma	Phase 1/Phase 2
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
Terminated	`NCT00990496` - A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)	Phase 1
Terminated	`NCT01044966` - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma	Phase 1/Phase 2
Completed	`NCT00402116` - Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients	Phase 1/Phase 2
Completed	`NCT00112502` - Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme	Phase 2
Completed	`NCT00504660` - 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients	Phase 2
Recruiting	`NCT05366179` - Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc	Phase 1