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New treatment option for High Grade Glioma
Official title STARLITE for Unresectable High-Grade Gliomas
ClinicalTrials.gov ID: NCT06428045
What this study is testing
What is Abacavir?
Abacavir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for high grade glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI. a. For cases with suspected HGG, intraoperative frozen section...
- Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
- 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.
- Preoperative Karnofsky score ≥ 70 (APPENDIX A).
You likely can't join if
- Patients with human leukocyte antigen (HLA) HLA-B\ 5701 hypersensitivity (Section 10.1.6.7).
- Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
- Patients with a previous history of HIV infection.
- Patients with uncontrolled hepatitis B or C infection.
- Patients who have received any surgical resection for this tumor. a. Patients who have received an open biopsy for this disease are still eligible...
- Patients who have received chemotherapy or radiation for this disease.
See the full eligibility criteria
- Age ≥ 18 years.
- 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).
- Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon.
- 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.
- Preoperative Karnofsky score ≥ 70 (APPENDIX A).
- Patients must have demonstrable normal organ function as defined below within 14 days of surgery.
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
- 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.
- Electrocardiogram (ECG) without evidence of acute cardiac ischemia.
- Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4
- Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN).
- Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.
- Patients must be able to understand and sign informed consent.
- Patients with human leukocyte antigen (HLA) HLA-B\ 5701 hypersensitivity (Section 10.1.6.7).
- Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1).
- Patients with a previous history of HIV infection.
- Patients with uncontrolled hepatitis B or C infection.
- 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.
- Patients who have received chemotherapy or radiation for this disease.
- Patients who are taking dofetilide (Section 4.10.1).
- 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...
- Patients not eligible to obtain MRI with and without contrast.
- Recurrent HGG.
- Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia.
- Fever within 48 hours of surgery (Temperature\> 38.0°C).
- Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician.
- Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy.
- Pregnant women.
- Patients must be willing to use contraception as described in Section 4.11.
- Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial.
- Prisoners.
- Adults unable to consent.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.