Combination Therapy for Glioblastoma

Palo Alto (17 mi)

Overseen byMichael Dominello, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Barbara Ann Karmanos Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial studies the side effects of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy for the treatment of newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chloroquine is normally used to treat strains of malaria and prior preclinical and clinical data suggests that it may increase the efficacy of both radiation and tumor treating fields therapy. Tumor treating fields therapy uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. The purpose of this study is to determine the safety of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy in patients with gliobastoma

Eligibility Criteria

This trial is for adults with newly diagnosed glioblastoma who have recovered from surgery without complications. They must not have had previous chemotherapy or radiosensitizers for head and neck cancers (except certain conditions), no severe heart disease, eye disorders, or other major illnesses that could interfere with the treatment. Women of childbearing potential must use effective contraception and have a negative pregnancy test.

Inclusion Criteria

I have been diagnosed with a grade IV brain tumor.

I am using birth control as required, if I can have children.

I am able to care for myself but may not be able to do active work.

I am a woman able to have children and have a recent negative pregnancy test.

Exclusion Criteria

Severe, active, co-morbidity defined as follows: Moderate or severe hepatic impairment (Child-Pugh category B or higher [score of 7 or higher ]); unstable angina and/or congestive heart failure within the last 6 months; transmural myocardial infarction within the last 6 months; evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days prior to enrollment; New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to enrollment; History of stroke, cerebral vascular accident (CVA), or transient ischemic attack within 6 months (except if intra- or post-operative); serious and inadequately controlled cardiac arrhythmia; acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment; uncontrolled human immunodeficiency virus (HIV) with CD4 count < 200; note, however, that HIV testing is not required for entry into this protocol; Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy; Subjects treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study, except intra-operative therapy to guide resection or experimental imaging without therapeutic intent; Inability to undergo contrast-enhanced MRI scans; Presence of implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain; Documented clinically significant arrhythmia or severe ischemic heart disease; Patients with underlying ocular disorders, including but not limited to: maculopathy, macular degeneration, and retinopathy

I have been cancer-free for 5 years, except for certain skin cancers and early-stage cancers.

I have been diagnosed with gliomatosis cerebri.

My brain cancer has spread to other parts of my body.

My tumor is located in the lower part of my brain.

I have a known G6PD deficiency.

My condition is recurrent glioblastoma.

I've had radiation on my head or neck, not for T1 glottic or non-melanoma skin cancer, with overlapping treatment areas.

Treatment Details

The study tests the combination of partial brain radiation therapy, temozolomide (a chemotherapy drug), chloroquine (an antimalarial drug thought to enhance cancer treatments), and tumor treating fields therapy (TTF) which uses electric fields to disrupt cancer cell growth in patients with glioblastoma.

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy, temozolomide, chloroquine, TTF)Experimental Treatment5 Interventions

Patients undergo 30 fractions of 3D CRT or Intensity-modulated radiation therapy (IMRT) and receive temozolomide by mouth (PO) and chloroquine PO daily from day 1 for the duration of radiation therapy up to day 49. Treatment continues in the absence of disease progression or unacceptable toxicity. ADJUVANT TREATMENT: Beginning 4 weeks after the last day of radiation therapy, patients receive temozolomide PO QD on days 1-5 and chloroquine PO daily on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients demonstrating continued benefit may continue to receive temozolomide and chloroquine for up to 12 cycles. Patients also undergo TTF therapy over 18 hours or longer per day.

3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as 3D-CRT for: