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Combination Therapy for Glioblastoma

Phase 1

Waitlist Available

Led By Michael Dominello, M.D.

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed newly diagnosed grade IV glioma (gliosarcoma allowed)

Female subjects of childbearing potential must practice at least one of the methods of birth control listed during study entry, for the entire duration of the study and for at least 6 months after treatment with temozolomide and chloroquine

Must not have

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

Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma in situ (CIS) of the breast, CIS oral cavity, or CIS cervix, T1 glottic cancer) unless disease free for >= 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 3 months of adjuvant therapy phase

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects of using partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy to treat patients with newly diagnosed glioblastoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include fatigue, skin irritation from radiation, nausea from chemotherapy, vision changes due to chloroquine, and scalp irritation from TTF. There may also be an increased risk of infections and blood-related issues such as low counts of white cells or platelets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a grade IV brain tumor.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with gliomatosis cerebri.

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

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

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I have a known G6PD deficiency.

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My condition is recurrent glioblastoma.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 3 months of adjuvant therapy phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 3 months of adjuvant therapy phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 3 months of adjuvant therapy phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who develop a specific acute toxicity (dermatitis)

Secondary study objectives

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7230