GlioblastomaPhase 1NCT04397679
Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma
A Phase 1 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy (IMRT) and Temozolomide in people with Glioblastoma and Gliosarcoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma
- What is being tested?
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy (IMRT) and Temozolomide
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 14 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed newly diagnosed grade IV glioma (gliosarcoma allowed)
- The subject must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment. Post-operative unenhanced and contrast-enhanced MRI scan should be done within 72 hours after surgery. If it is not obtained within 72 hours post-resection, then an MRI obtained at least 2 weeks (or longer) after surgery is required
- Karnofsky performance status >= 70%
- Absolute neutrophil count >= 1,500/mm^3 (=< 21 days prior to registration)
- Platelets >= 100,000/mm^3 (=< 21 days prior to registration)
- Hemoglobin (Hgb) >= 9.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb >= 9.0 g/dL is acceptable.) (=< 21 days prior to registration)
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- Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula (=< 21 days prior to registration)
- Total bilirubin =< 1.5 times upper limit of normal (ULN) (=< 21 days prior to registration)
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 1.5 times upper limit of normal (ULN) (=< 21 days prior to registration)
- Female subjects of childbearing potential (i.e., those who are not postmenopausal for at least 1 year or surgically sterile by bilateral tubal ligation, bilateral oophorectomy or hysterectomy) and their male partners should practice at least one of the methods of birth control listed below during study entry, for the entire duration of the study and for at least 6 months after treatment with temozolomide and chloroquine:
- A vasectomized male subject or a vasectomized partner of a female subject; hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to study drug administration; intrauterine device (females); double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
- Female subjects of child-bearing potential must have a negative pregnancy test (urine or serum) within 3 days of registration
- Must voluntarily sign and date informed consent form for study participation, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
Who cannot join
- Gliomatosis cerebri (a diffuse glioma [usually astrocytic] growth pattern consisting of exceptionally extensive infiltration of a large region of the central nervous system, with involvement of at least 3 cerebral lobes, usually with bilateral involvement of the cerebral hemispheres and/or deep grey matter, and frequent extension to the brain stem, cerebellum, and even the spinal cord.)
- Recurrent glioblastoma (GBM)
- Metastatic GBM
- Infratentorial tumor
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Implanted carmustine (BCNU) wafer is allowed
- Prior radiotherapy to the head or neck (except for T1 glottic cancer or nonmelanomatous skin cancer), resulting in overlap of radiation fields
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- Any prior therapy for glioblastoma besides surgery (intra-operative techniques to guide resection and experimental imaging techniques are allowed). BCNU wafer is allowed
- 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
- Prior, concomitant, or planned concomitant treatment with bevacizumab, carmustine implant (Gliadel) wafers or other intratumoral or intracavitary anti-neoplastic therapy, or other experimental therapeutics intended to treat the tumor; the exceptions are diagnostic and operative guides to improve extent of resection or imaging studies, quality of life, biomarker, or epidemiological studies
- History of hypersensitivity to temozolomide or excipients
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Lactating or pregnant female
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Treatment of Adults with Newly Diagnosed Glioblastoma with Partial Brain Radiation Therapy Plus Temozolomide and Chloroquine Followed by Tumor Treating Fields Plus Temozolomide and Chloroquine -- a Pilot Study
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
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety of partial brain radiation therapy plus temozolomide and chloroquine followed by tumor treating fields (TTFs) plus temozolomide and chloroquine, specifically grade 3 or higher dermatitis within the first 3 months of the adjuvant therapy phase.
SECONDARY OBJECTIVE:
- To measure treatment effect via advanced magnetic resonance imaging (MRI) and alpha-[11C]methyl-L-tryptophan (AMT)-positron emission tomography (PET).
OUTLINE:
Patients undergo 30 fractions of 3-dimensional conformal radiation therapy (3D CRT) or intensity-modulated radiation therapy (IMRT) and receive temozolomide orally (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 once daily (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.
After completion of study treatment, patients are followed up monthly for 3 months.
- Conditions
- Glioblastoma, Gliosarcoma
- Being tested
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy (IMRT), Temozolomide, Chloroquine, Tumor Treating Fields Therapy (TTF)
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Dimensional Conformal Radiation TherapyRadiation
Also called 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT
Undergo 3D CRT
Intensity-Modulated Radiation Therapy (IMRT)Radiation
Also called IMRT, Intensity Modulated RT, INTENSITY-MODULATED RADIATION THERAPY, Intensity-Modulated Radiotherapy
Undergo IMRT
TemozolomideDrug
Also called 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 362856, 8-carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one, 85622-93-1, CCRG-81045, imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, Imidazo[5,1-d]
Given PO
ChloroquineDrug
Also called 54-05-7
Given PO
Tumor Treating Fields Therapy (TTF)Procedure or surgery
Also called Alternating Electric Field Therapy, TTF, TTFields
Undergo TTF
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy, temozolomide, chloroquine, TTF) | Experimental | 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. Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy (IMRT); Drug: Temozolomide; Drug: Chloroquine; Procedure: Tumor Treating Fields Therapy (TTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who develop a specific acute toxicity (dermatitis)
Will summarize dermatitis status
Measured: First 3 months of adjuvant therapy phase
Secondary outcomes (1)
Incidence of adverse events
Will detail the safety profile and measure (via magnetic resonance imaging and positron emission tomography scans) the uptake and retention of alpha-[11C]methyl-L-tryptophan.
Measured: First 3 months of adjuvant therapy phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start12 Aug 2021
- Primary completion14 May 2024
- Study completion14 May 2024
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dominello, Barbara Ann Karmanos Cancer Institute
- Investigators
- Michael Dominello, M.D., Principal investigator, Barbara Ann Karmanos Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397679
- Sponsor's protocol ID
- 2018-148
- Status last verified
- Jan 2025
- First submitted
- 18 May 2020
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adults with Newly Diagnosed Glioblastoma with Partial Brain Radiation Therapy Plus Temozolomide and Chloroquine Followed by Tumor Treating Fields Plus Temozolomide and Chloroquine -- a Pilot Study
- ClinicalTrials.gov ID
- NCT04397679
- Acronym / sponsor ID
- 2018-148
- Conditions
- Glioblastoma, Gliosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVE:
- To determine the safety of partial brain radiation therapy plus temozolomide and chloroquine followed by tumor treating fields (TTFs) plus temozolomide and chloroquine, specifically grade 3 or higher dermatitis within the first 3 months of the adjuvant therapy phase.
SECONDARY OBJECTIVE:
- To measure treatment effect via advanced magnetic resonance imaging (MRI) and alpha-[11C]methyl-L-tryptophan (AMT)-positron emission tomography (PET).
OUTLINE:
Patients undergo 30 fractions of 3-dimensional conformal radiation therapy (3D CRT) or intensity-modulated radiation therapy (IMRT) and receive temozolomide orally (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 once daily (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.
After completion of study treatment, patients are followed up monthly for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy, temozolomide, chloroquine, TTF) | Experimental | Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy (IMRT), Drug: Temozolomide, Drug: Chloroquine, Procedure: Tumor Treating Fields Therapy (TTF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed newly diagnosed grade IV glioma (gliosarcoma allowed)
- The subject must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment. Post-operative unenhanced and contrast-enhanced MRI scan should be done within 72 hours after surgery. If it is not obtained within 72 hours post-resection, then an MRI obtained at least 2 weeks (or longer) after surgery is required
- Karnofsky performance status >= 70%
- Absolute neutrophil count >= 1,500/mm^3 (=< 21 days prior to registration)
- Platelets >= 100,000/mm^3 (=< 21 days prior to registration)
Key exclusion criteria (21 listed)
- Gliomatosis cerebri (a diffuse glioma [usually astrocytic] growth pattern consisting of exceptionally extensive infiltration of a large region of the central nervous system, with involvement of at least 3 cerebral lobes, usually with bilateral involvement of the cerebral hemispheres and/or deep grey matter, and frequent extension to the brain stem, cerebellum, and even the spinal cord.)
- Recurrent glioblastoma (GBM)
- Metastatic GBM
- Infratentorial tumor
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Implanted carmustine (BCNU) wafer is allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Dimensional Conformal Radiation TherapyAlso: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRTUndergo 3D CRT | Radiation | Treatment (radiation therapy, temozolomide, chloroquine, TTF) |
| Intensity-Modulated Radiation Therapy (IMRT)Also: IMRT, Intensity Modulated RT, INTENSITY-MODULATED RADIATION THERAPY, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Treatment (radiation therapy, temozolomide, chloroquine, TTF) |
| TemozolomideAlso: 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 362856, 8-carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one, 85622-93-1, CCRG-81045, imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, Imidazo[5,1-d]Given PO | Drug | Treatment (radiation therapy, temozolomide, chloroquine, TTF) |
| ChloroquineAlso: 54-05-7Given PO | Drug | Treatment (radiation therapy, temozolomide, chloroquine, TTF) |
| Tumor Treating Fields Therapy (TTF)Also: Alternating Electric Field Therapy, TTF, TTFieldsUndergo TTF | Procedure or surgery | Treatment (radiation therapy, temozolomide, chloroquine, TTF) |
Primary outcome
Proportion of patients who develop a specific acute toxicity (dermatitis)
Time frame: First 3 months of adjuvant therapy phase
Will summarize dermatitis status
1 secondary outcome
Incidence of adverse events
Time frame: First 3 months of adjuvant therapy phase
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dominello, M.D. principal investigator
Barbara Ann Karmanos Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy (IMRT) and Temozolomide in people with Glioblastoma and Gliosarcoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who develop a specific acute toxicity (dermatitis) (time frame: First 3 months of adjuvant therapy phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.