Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06428045
Other study ID # 20231163
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 31, 2024
Est. completion date May 31, 2029

Study information

Verified date May 2024
Source University of Miami
Contact Ashish Shah, MD
Phone (305) 243-6946
Email ashah@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date May 31, 2029
Est. primary completion date May 31, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years. 2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI. a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1). 3. Uni-focal or butterfly gliomas that can receive =70% of lesion volume ablated as determined by the treating surgeon. 4. Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists. 5. Preoperative Karnofsky score = 70 (APPENDIX A). 6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery. 1. Absolute neutrophil count (ANC) = 1500 cells/mm3 2. Platelets = 100,000 cells/mm3 3. Hemoglobin = 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable. 4. Blood urea nitrogen (BUN) = 35 mg/dL and creatinine = 1.9 mg/dL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate > 50 mL per minute. 5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia. 6. Prothrombin time (PT)/International Normalized Ratio (INR) <1.4 7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN). 8. Sodium level > 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable. 7. Patients must be able to understand and sign informed consent. Exclusion Criteria: 1. Patients with human leukocyte antigen (HLA) HLA-B*5701 hypersensitivity (Section 10.1.6.7). 2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1). 3. Patients with a previous history of HIV infection. 4. Patients with uncontrolled hepatitis B or C infection. 5. Patients who have received any surgical resection for this tumor. a. Patients who have received an open biopsy for this disease are still eligible for participation. 6. Patients who have received chemotherapy or radiation for this disease. 7. Patients who are taking dofetilide (Section 4.10.1). 8. Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10. 9. Patients not eligible to obtain MRI with and without contrast. 10. Recurrent HGG. 11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia. 12. Fever within 48 hours of surgery (Temperature> 38.0°C). 13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician. 14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy. 15. Pregnant women. 16. Patients must be willing to use contraception as described in Section 4.11. 17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial. 18. Prisoners. 19. Adults unable to consent.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy.
Drug:
Abacavir
Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).
Lamivudine
Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)
Ritonavir
Participants will take one tablet of Ritonavir (RTV) orally twice daily, as part of combination antiretroviral therapy (ART), at one of the following dose levels: Dose Level -1: 100mg Dose Level 1 (starting dose): 300mg Dose Level 2: 450mg Dose Level 3: 600mg
Temozolomide
Participants will take Temozolomide (TMZ) via capsule orally, during and after focal radiotherapy, as part of standard of care adjuvant therapy. During focal radiotherapy, Temozolomide will be administered at a dose of 75 mg/m2 once daily for six weeks (42 days) on a continuous dosing regimen, including weekends and holidays. After completion of focal radiotherapy, Temozolomide will be administered 150-200 mg/m2 on days 1 through 5 of a four-week cycle for a total of six cycles of maintenance therapy.
Radiation:
Focal Radiotherapy
Participants will be administered focal radiotherapy for six weeks (42 days), as part of adjuvant therapy, at a total dose of 50-60 grays (Gy) in 1.8-2.0 Gy fractions, depending on prognosis and as determined by the treating radiation oncologist.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Dose-Limiting Toxicity The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0). Up to 28 days
Primary Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0). Up to 12 months
Secondary Progression-Free Survival (PFS) PFS is defined as percentage of participants without disease progression at time of study discontinuation. Up to 24 months
Secondary Overall Survival (OS) Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation. Up to 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05023551 - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Completed NCT01466686 - Low Dose Radiation Therapy for Glioblastoma Multiforme Phase 2
Recruiting NCT05925218 - Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Recruiting NCT05212272 - MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Recruiting NCT04734444 - SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue N/A
Completed NCT03775369 - Glioma and Exercising N/A
Completed NCT02022644 - Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma Phase 1
Completed NCT00780819 - Borderzone Sampling N/A
Recruiting NCT06072586 - Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions Early Phase 1
Completed NCT01390948 - A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Phase 2
Recruiting NCT03952598 - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy N/A
Recruiting NCT05630664 - Liquid Biopsy in High-grade Gliomas and Meningiomas
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1
Completed NCT01222754 - Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT05278208 - Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors Phase 1/Phase 2