OncoMatch/Clinical Trials/NCT06428045

STARLITE for Unresectable High-Grade Gliomas

Is NCT06428045 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Abacavir and Lamivudine for high grade glioma.

Phase 1RecruitingUniversity of MiamiNCT06428045Data as of May 2026

Treatment: Abacavir · Lamivudine · Ritonavir · Temozolomide — 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Excluded: HLA-B HLA-B*5701 hypersensitivity

Patients with human leukocyte antigen (HLA) HLA-B*5701 hypersensitivity

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: surgical resection

Exception: open biopsy allowed

Cannot have received: chemotherapy

Cannot have received: radiation therapy

Lab requirements

Blood counts

ANC ≥ 1500 cells/mm3; platelets ≥ 100,000 cells/mm3; hemoglobin ≥ 9.0 g/dL (transfusion/intervention allowed)

Kidney function

BUN ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and eGFR or creatinine clearance rate > 50 mL/min

Liver function

AST and ALT ≤ 2.5x ULN

Cardiac function

ECG without evidence of acute cardiac ischemia; PT/INR <1.4; sodium > 130 mg/L (salt resection/hypertonic saline allowed)

Patients must have demonstrable normal organ function as defined below within 14 days of surgery. 1. 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. BUN ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and eGFR or creatinine clearance rate > 50 mL per minute. 5. ECG without evidence of acute cardiac ischemia. 6. PT/INR <1.4 7. AST and ALT ≤ 2.5x ULN. 8. Sodium level > 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

University of Miami · Miami, Florida

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