GlioblastomaEarly Phase 1NCT02768389
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
A Early Phase 1 study testing Bevacizumab and Modified Atkins Diet in people with Glioblastoma and Brain Tumor, run by Case Comprehensive Cancer Center at 4 sites in United States.
Trial summary
Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Brain Tumor
- What is being tested?
- Bevacizumab and Modified Atkins Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Sep 2016to Nov 2018
- Phase
- Early 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
- Patients must have histologically or cytologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external beam fractionated radiotherapy and temozolomide chemotherapy.
- Any number of prior recurrences are allowed
- Karnofsky Performance status ≥60
- Patients must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count ≥ 1.5 x 10^9/L
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- Platelet count ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.5 X institutional upper limit of normal
- Aspartate aminotransferase (AST) (SGOT) ≤ 3.0x institutional upper limit of normal
- Alanine aminotransferase (ALT) (SGPT) ≤ 3.0x institutional upper limit of normal
- Serum Creatinine ≤ 1.5 X institutional upper limit of normal
- Cr <2, blood urea nitrogen (BUN) < 100mg/dL
- Blood coagulation parameters: international normalized ratio (INR) ≤ 1.5
- Minimum interval since last drug therapy;
- 3 weeks since last non-cytotoxic therapy
- 3 weeks must have elapsed since the completion of non-nitrosourea-containing chemotherapy regimen.
- 6 weeks since the completion of a non-nitrosourea-containing therapy regimen.
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treatment stage I or II cancer from which the patient is in complete remission. Patients with other malignancies must also be disease free for at least three years.
- Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of the treatment and/or for at least 5 days before starting treatment.
- Patients with the potential for pregnancy or impregnating their partners must agree to follow acceptable birth control methods to avoid conception. The effects of bevacizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence prior to study entry, for the duration of study participation and after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab.
- Patients who have had previous treatment with bevacizumab.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active bowel instruction, diabetic (insulin dependent), Active or remote pancreatitis, Pancreatic insufficiency, symptomatic congestive heart failure (NYHA > 2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because bevacizumab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with bevacizumab, breastfeeding should be discontinued if the mother is treated with bevacizumab. These potential risks may also apply to other agents used in this study.
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- Known diagnosis of human immunodeficiency virus (HIV). (HIV testing is not required).
- Patients who have undergone major surgery (ie, intra-thoracic, intra abdominal or inra-pelvic), open biopsy or significant traumatic injury =< 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of previous procedure or injury.
- Patients with cirrhosis, or active viral or nonviral hepatitis.
- Implanted pacemaker, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain or other documented clinically significant arrhythmias.
- Evidence of increased intracranial pressure (clinically significant papilledema, vomiting, and nausea, or reduced level of consciousness).
- Patients who are unwilling to comply with protocol.
- Myocardial infarction within the last 6 months.
- Symptomatic atrial fibrillation.
- Patients with a body mass index (BMI) >35, < 20.
- Patients with a genetic disorder of fat metabolism.
- Patients who are allergic to milk.
- Insulin dependent diabetes mellitus.
- Patients with uncontrolled hypertension. Patients with a history of hypertension must be well controlled (<160/90) on a regimen of hypertensive medication.
- Patients with known inborn errors of metabolism of primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency and porphyria.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Cincinnati
Cincinnati, Ohio, 45220
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive cancer Center
Cleveland, Ohio, 44195
OhioHealth Research and Innovation Institute
Columbus, Ohio, 43214
About this study
Official title: A Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD).
The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.
Read the detailed description
Primary Objective
- Determine compliance to treatment at 6 and 12 weeks. Compliance is assessed by review of the daily food diary and the urine and serum ketone levels. Diet compliance is defined as following the diet guidelines 80% of the time with resultant ketosis 80% of the time. If 60% of the patients are compliant with the diet, as defined above, that is a considered a positive result.
Secondary Objective(s)
- Determine patient compliance in monitoring of blood glucose and urine levels of ketosis.
- Determine obstacles to compliance.
- Determine the frequency of achieving ketosis, as measured by urine ketones checked daily and serum BHB checked every two weeks.
- Determine quality of life (FACT-BR) and adverse events.
- Determine response, progression free survival at 6 months (PFS 6), and overall survival (OS).
Exploratory Objective
- To correlate levels of ketosis and blood sugar with treatment outcome.
- To correlate the level of MCT4 expression and IDH1 mutation status with treatment outcome.
- Conditions
- Glioblastoma, Brain Tumor
- Being tested
- Bevacizumab, Modified Atkins Diet
- Keywords
- Modified Atkins Diet, MAD, Brain Tumor, Glioblastoma
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Subjects receive Bevacizumab as standard of care
Modified Atkins DietBehavioural
Also called MAD
The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (< 20gm/day).
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet and Bevacizumab | Experimental | Patients and caregivers will be educated by a nutritionist skilled in the MAD. Patients will also be receiving Bevacizumab as standard of care. Receives: Drug: Bevacizumab; Behavioral: Modified Atkins Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects following Modified Atkins Diet
The number of patients following a Modified Atkins Diet for at least 80% of the time as a measure of feasibility
Measured: Up to 12 weeks
Number of subjects with ketosis
The number of patients with documented ketosis (Serum beta-hydroxybutyrate (BHB) above 4mg/L) for at least 80% of the time as a measure of feasibility
Measured: Up to 12 weeks
Secondary outcomes (4)
Correlation of blood sugar levels by compliance level
Correlate the relationship between blood sugar levels and measured level of compliance
Measured: Up to 12 weeks
Correlation of ketosis values by compliance level
Correlate the relationship between ketosis values and measured level of compliance
Measured: Up to 12 weeks
Correlation of ketosis values by tumor response
Correlate the relationship between ketosis values and measured level of tumor response as a measure of treatment outcomes
Measured: Up to 12 weeks
Correlation of blood sugar levels by tumor response
Correlate the relationship between blood sugar levels and measured level of tumor response as a measure of treatment outcomes
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start6 Sep 2016
- Primary completionNov 2018
- Study completionNov 2018
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.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, OhioHealth Research Institute
- Responsible party
- Sponsor
- Investigators
- Lisa Rogers, DO, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768389
- Sponsor's protocol ID
- CASE10314
- Status last verified
- Mar 2019
- First submitted
- 9 May 2016
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT02768389
- Acronym / sponsor ID
- CASE10314
- Conditions
- Glioblastoma, Brain Tumor
- Keywords
- Modified Atkins Diet, MAD, Brain Tumor, Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University of Cincinnati, OhioHealth Research Institute
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD).
The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.
Detailed description
Primary Objective
- Determine compliance to treatment at 6 and 12 weeks. Compliance is assessed by review of the daily food diary and the urine and serum ketone levels. Diet compliance is defined as following the diet guidelines 80% of the time with resultant ketosis 80% of the time. If 60% of the patients are compliant with the diet, as defined above, that is a considered a positive result.
Secondary Objective(s)
- Determine patient compliance in monitoring of blood glucose and urine levels of ketosis.
- Determine obstacles to compliance.
- Determine the frequency of achieving ketosis, as measured by urine ketones checked daily and serum BHB checked every two weeks.
- Determine quality of life (FACT-BR) and adverse events.
- Determine response, progression free survival at 6 months (PFS 6), and overall survival (OS).
Exploratory Objective
- To correlate levels of ketosis and blood sugar with treatment outcome.
- To correlate the level of MCT4 expression and IDH1 mutation status with treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet and Bevacizumab | Experimental | Drug: Bevacizumab, Behavioral: Modified Atkins DietPatients and caregivers will be educated by a nutritionist skilled in the MAD. Patients will also be receiving Bevacizumab as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external beam fractionated radiotherapy and temozolomide chemotherapy.
- Any number of prior recurrences are allowed
- Karnofsky Performance status ≥60
- Patients must have normal organ and marrow function as defined below:
- Minimum interval since last drug therapy;
Key exclusion criteria (20 listed)
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab.
- Patients who have had previous treatment with bevacizumab.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active bowel instruction, diabetic (insulin dependent), Active or remote pancreatitis, Pancreatic insufficiency, symptomatic congestive heart failure (NYHA > 2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| BevacizumabSubjects receive Bevacizumab as standard of care | Drug | Modified Atkins Diet and Bevacizumab |
| Modified Atkins DietAlso: MADThe modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (< 20gm/day). | Behavioural | Modified Atkins Diet and Bevacizumab |
Primary outcome
Number of subjects following Modified Atkins Diet
Time frame: Up to 12 weeks
The number of patients following a Modified Atkins Diet for at least 80% of the time as a measure of feasibility
Number of subjects with ketosis
Time frame: Up to 12 weeks
The number of patients with documented ketosis (Serum beta-hydroxybutyrate (BHB) above 4mg/L) for at least 80% of the time as a measure of feasibility
4 secondary outcomes
Correlation of blood sugar levels by compliance level
Time frame: Up to 12 weeks
Correlation of ketosis values by compliance level
Time frame: Up to 12 weeks
Correlation of ketosis values by tumor response
Time frame: Up to 12 weeks
Correlation of blood sugar levels by tumor response
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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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.
Lisa Rogers, DO principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bevacizumab and Modified Atkins Diet in people with Glioblastoma and Brain Tumor, run by Case Comprehensive Cancer Center at 4 sites 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 21 inclusion and 20 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: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects following Modified Atkins Diet (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 Mar 2019.