Actively Recruiting
STARLITE for Unresectable High-Grade Gliomas
Led by University of Miami · Updated on 2025-06-22
24
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STARLITE for Unresectable High-Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed or suspected high-grade glioma by MRI
- For suspected cases, intraoperative frozen section diagnosis confirming high-grade glioma
- Glioma must be unifocal or butterfly type allowing at least 70% lesion volume ablation
- Glioma location must be not suitable or high-risk for surgical removal as determined by neuro-oncologists
- Preoperative Karnofsky score of 70 or higher
- Normal organ function within 14 days before surgery including specified blood counts, kidney and liver function, ECG and coagulation measures
- Ability to understand and sign informed consent
You will not qualify if you...
- Known hypersensitivity to HLA-B*5701
- Sensitivity to Abacavir, Lamivudine, or Ritonavir
- Previous history of HIV infection
- Uncontrolled hepatitis B or C infection
- Prior surgical resection for tumor (open biopsy allowed)
- Prior chemotherapy or radiation for this tumor
- Use of dofetilide or prohibited medications that cannot be discontinued
- Inability to undergo MRI with and without contrast
- Recurrent high-grade glioma
- Current infection such as sepsis, meningitis, bacteremia, or pneumonia
- Fever over 38.0 0C within 48 hours before surgery
- Severe co-morbidities increasing risk of surgery, radiation, or chemotherapy
- Co-morbidities or psychiatric conditions preventing protocol therapy
- Pregnancy
- Unwillingness to use contraception
- Concurrent participation in other therapeutic clinical trials
- Prisoner status
- Adults unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
A
Ashish Shah, MD
CONTACT
M
Macarena De La Fuente, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here