Trial Title:
STARLITE for Unresectable High-Grade Gliomas
NCT ID:
NCT06428045
Condition:
High Grade Glioma
Conditions: Official terms:
Glioma
Ritonavir
Lamivudine
Abacavir
Temozolomide
Conditions: Keywords:
Unresectable High Grade Glioma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1 dose escalation/de-escalation and dose expansion design.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
Description:
Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as
a single procedure, following stereotactic needle biopsy.
Arm group label:
Part 1: STARLITE Dose Escalation/De-Escalation Cohort
Arm group label:
Part 2: STARLITE Dose Expansion Cohort
Other name:
MR-Guided LITT
Intervention type:
Drug
Intervention name:
Abacavir
Description:
Participants will take one 600mg tablet of Abacavir orally once daily, as part of
combination antiretroviral therapy (ART).
Arm group label:
Part 1: STARLITE Dose Escalation/De-Escalation Cohort
Arm group label:
Part 2: STARLITE Dose Expansion Cohort
Intervention type:
Drug
Intervention name:
Lamivudine
Description:
Participants will take one 300mg tablet of Lamivudine orally once daily, as part of
combination antiretroviral therapy (ART)
Arm group label:
Part 1: STARLITE Dose Escalation/De-Escalation Cohort
Arm group label:
Part 2: STARLITE Dose Expansion Cohort
Intervention type:
Drug
Intervention name:
Ritonavir
Description:
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
Arm group label:
Part 1: STARLITE Dose Escalation/De-Escalation Cohort
Arm group label:
Part 2: STARLITE Dose Expansion Cohort
Other name:
Norvir
Other name:
RTV
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
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.
Arm group label:
Part 1: STARLITE Dose Escalation/De-Escalation Cohort
Arm group label:
Part 2: STARLITE Dose Expansion Cohort
Other name:
TMZ
Intervention type:
Radiation
Intervention name:
Focal Radiotherapy
Description:
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.
Arm group label:
Part 1: STARLITE Dose Escalation/De-Escalation Cohort
Arm group label:
Part 2: STARLITE Dose Expansion Cohort
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Ashish Shah, MD
Phone:
305-243-6946
Email:
ashah@med.miami.edu
Contact backup:
Last name:
Macarena De La Fuente, MD
Phone:
(305) 243-2858
Email:
MDelaFuente@med.miami.edu
Investigator:
Last name:
Ashish Shah, MD
Email:
Principal Investigator
Investigator:
Last name:
Macarena De La Fuente, MD
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
May 31, 2029
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
Medtronic
Agency class:
Industry
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428045
