Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks.

To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery.

Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Subjects must have suspected high grade glioma by MRI

• Subjects must have received no prior therapies for this disease.

• Patients must be considered appropriate candidates for LITT.

• Karnofsky Performance status ≥ 60%

• Subjects must have normal organ and marrow function as defined below. Measures of function must be within 14 days prior to registration.

• Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 10.0 g/dl. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.

• Blood urea nitrogen ≤ 30mg/dl and creatinine ≤ 1.7 mg/dl

• Bilirubin ≤ 2.0 mg/dl, Aspartate aminotransferase/ Alanine aminotransferase (AST/ALT) ≤ 3x upper limit of normal

• Electrocardiogram without evidence of acute cardiac ischemia

• Prothrombin time/international normalized ratio (PT INR) <1.4

• Women of childbearing potential and male participants must practice adequate contraception.

• For women of childbearing age, negative pregnancy test within 14 days prior to registration

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Participants not eligible to obtain MRI with and without contrast

• Recurrent High grade gliomas (HGG)

• Cerebral edema, grade 3 or greater prior to surgery

• Post-operative complications including significant neurological decline or hemorrhage that causes a drop in KPS to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician

• Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician.

Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration of completion of protocol therapy

• Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.

• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

• Participants receiving other investigational agents.