Glioblastoma MultiformeNCT07553520
Dietary Cysteine and Methionine Deprivation (CMD) in Glioma Patients
A study testing Normal diet, Cysteine/methionine deprivation (CMD) diet for 2 days and Cysteine/methionine deprivation (CMD) diet for 4 days in people with Glioblastoma Multiforme and Recurrent Glioma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot study looks at how certain diet changes affect the body in patients with recurrent brain tumors (glioma) who are planning to have standard treatment like radiation or surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Recurrent Glioma
- What is being tested?
- Normal diet, Cysteine/methionine deprivation (CMD) diet for 2 days and Cysteine/methionine deprivation (CMD) diet for 4 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Jul 2028
- Phase
- Interventional
- 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
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of consent.
- Karnofsky Performance Status of ≥ 60 assessed at diagnosis
Who cannot join
- Active infection requiring systemic therapy.
- Any active disease that may be associated with unacceptable anesthetic/operative risk.
- Pregnant or breastfeeding
- Subjects with prior brain metastasis.
- Transfusion within 7 days of diet initiation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27514
About this study
Official title: A Pilot Study Examining Dietary Restriction of Sulfur Containing Amino Acids by Cysteine and Methionine Deprivation (CMD) in Glioma Patients
This pilot study looks at how certain diet changes affect the body in patients with recurrent brain tumors (glioma) who are planning to have standard treatment like radiation or surgery. Up to 30 patients will be randomly assigned to either a regular diet or a special diet that limits two nutrients (cysteine and methionine) for 2, 4, or 7 days before their treatment.
Patients will be monitored for side effects using blood tests and questionnaires, and patients will keep a diary to track how well they follow the diet. Blood and urine samples will be used to see how the diet affects the body. Tumor samples (from surgery) will help researchers study how the cancer cells behave, and stool samples will be used to look at gut bacteria.
Read more
This is a randomized, blinded interventional pilot study to measure glutathione metabolite levels with a cysteine/methionine deprivation (CMD) diet in glioma patients. A menu of pre-prepared meals will be provided to subjects that consist of either a control diet or a CMD diet. The CMD diet will be implemented simultaneously in 2 cohorts of participants with recurrent glioma.
The primary objective will be to measure the metabolic state of glioblastome multiforme tumor cells through dietary restriction of the sulfur-containing amino acids (SAA), cysteine/cystine and methionine.
Patient from cohort A can later be included in Cohort B if applicable. Patients will be followed for progression free survival and overall survival for up to 1 year, or until they discontinue or are removed from the study for exploratory endpoints.
- Conditions
- Glioblastoma Multiforme, Recurrent Glioma
- Being tested
- Normal diet, Cysteine/methionine deprivation (CMD) diet for 2 days, Cysteine/methionine deprivation (CMD) diet for 4 days
- Keywords
- glutathione metabolites, dietary restriction of cysteine, dietary restriction of methionine, radiation, surgery
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dietOther
Participants receive normal diet.
Cysteine/methionine deprivation (CMD) diet for 2 daysOther
Participants receive cysteine/methionine deprivation (CMD) diet for 2 days.
Cysteine/methionine deprivation (CMD) diet for 4 daysOther
receive cysteine/methionine deprivation (CMD) diet for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Surgery Control | Active comparator | Participants will undergo surgery and receive a normal diet. Receives: Other: Normal diet |
| Cohort A: Surgery Diet Restriction 2 days | Experimental | Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 2 days. Receives: Other: Cysteine/methionine deprivation (CMD) diet for 2 days |
| Cohort A: Surgery Diet Restriction 4 days | Experimental | Participants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 4 days. Receives: Other: Cysteine/methionine deprivation (CMD) diet for 4 days |
| Cohort B: Radiation Therapy Control | Active comparator | Participants will undergo radiation therapy and receive a normal diet. Receives: Other: Normal diet |
| Cohort B: Radiation Therapy 2 days | Experimental | Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 2 days. Receives: Other: Cysteine/methionine deprivation (CMD) diet for 2 days |
| Cohort B: Radiation Therapy 4 days | Experimental | Participants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 4 days. Receives: Other: Cysteine/methionine deprivation (CMD) diet for 4 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic glutathione metabolites
Systemic glutathione metabolite levels in blood and urine will be assessed before and after a 2-day randomized assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet. Measurements will be obtained using laboratory assays and Magnetic resonance (MR) spectroscopy. Analyses will be conducted overall and stratified by patients scheduled for standard-of-care (SOC) radiation therapy or surgery.
Measured: Baseline and up to 4 days
Secondary outcomes (6)
Change in systemic glutathione metabolites
Glutathione metabolite levels in blood and urine will be measured before and after assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet. regimen using laboratory assays and Magnetic resonance (MR) spectroscopy. The pre-diet assessment will occur after a 2-day fast, and the post-diet assessment will occur after 4 days on the assigned diet (CMD or control).
Measured: Baseline and up to 6 days
Change in tumor tissue glutathione metabolites
Local tumor tissue metabolite levels will be assessed in resected glioma specimens from patients in the surgical cohort following assigned diet (normal or Cysteine and methionine deprivation (CMD) for 2 days and 4 days) diet. regimens. Metabolite levels will be measured using laboratory assays and Magnetic resonance (MR) spectroscopy to evaluate changes associated with acute CMD exposure.
Measured: At time of surgical resection and up to 6 days
Compliance with assigned diet regimen
The proportion of patients who achieve 100% compliance with their assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet. regimen will be assessed. The numerator is the number of patients with complete diet adherence, and the denominator is the total number of patients randomized to each diet. Compliance will be calculated separately for the 2-day and 4-day CMD regimens.
Measured: Baseline and up to 6 days.
Safety of normal or Cysteine and methionine deprivation diet
Safety will be evaluated in patients receiving normal or Cysteine and methionine deprivation (CMD) 2-day or 4-day diet from randomization through 30 days after standard-of-care surgery or radiation. Assessments will include hematology, serum chemistry, and adverse events graded per The NCI Common Terminology Criteria for Adverse Events (AE) is a descriptive terminology (CTCAE). CTCAE is a grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 30 days
Progression-Free Survival (PFS)
PFS will be assessed in patients randomized to each diet regimen following surgery or radiation. PFS is defined as the time from the start of the prescribed diet to disease progression or death from any cause, whichever occurs first. Data will be obtained via medical record abstraction at 1 year.
Measured: 1 year
Overall Survival
OS will be described for evaluable a patients randomized to each diet regimen following surgery or radiation. OS will be defined as the time from the start of the prescribed diet to death from any cause and obtained via medical record abstraction at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Why it stopped: Not stated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by UNC Lineberger 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Higgins, MD, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553520
- Sponsor's protocol ID
- LCCC2249
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining Dietary Restriction of Sulfur Containing Amino Acids by Cysteine and Methionine Deprivation (CMD) in Glioma Patients
- ClinicalTrials.gov ID
- NCT07553520
- Acronym / sponsor ID
- LCCC2249
- Conditions
- Glioblastoma Multiforme, Recurrent Glioma
- Keywords
- glutathione metabolites, dietary restriction of cysteine, dietary restriction of methionine, radiation, surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not stated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Apr 2026 (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 pilot study looks at how certain diet changes affect the body in patients with recurrent brain tumors (glioma) who are planning to have standard treatment like radiation or surgery. Up to 30 patients will be randomly assigned to either a regular diet or a special diet that limits two nutrients (cysteine and methionine) for 2, 4, or 7 days before their treatment.
Patients will be monitored for side effects using blood tests and questionnaires, and patients will keep a diary to track how well they follow the diet. Blood and urine samples will be used to see how the diet affects the body. Tumor samples (from surgery) will help researchers study how the cancer cells behave, and stool samples will be used to look at gut bacteria.
This is a randomized, blinded interventional pilot study to measure glutathione metabolite levels with a cysteine/methionine deprivation (CMD) diet in glioma patients. A menu of pre-prepared meals will be provided to subjects that consist of either a control diet or a CMD diet. The CMD diet will be implemented simultaneously in 2 cohorts of participants with recurrent glioma.
The primary objective will be to measure the metabolic state of glioblastome multiforme tumor cells through dietary restriction of the sulfur-containing amino acids (SAA), cysteine/cystine and methionine.
Patient from cohort A can later be included in Cohort B if applicable. Patients will be followed for progression free survival and overall survival for up to 1 year, or until they discontinue or are removed from the study for exploratory endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Surgery Control | Active comparator | Other: Normal dietParticipants will undergo surgery and receive a normal diet. |
| Cohort A: Surgery Diet Restriction 2 days | Experimental | Other: Cysteine/methionine deprivation (CMD) diet for 2 daysParticipants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 2 days. |
| Cohort A: Surgery Diet Restriction 4 days | Experimental | Other: Cysteine/methionine deprivation (CMD) diet for 4 daysParticipants will undergo surgery and receive a cysteine/methionine deprivation (CMD) diet for 4 days. |
| Cohort B: Radiation Therapy Control | Active comparator | Other: Normal dietParticipants will undergo radiation therapy and receive a normal diet. |
| Cohort B: Radiation Therapy 2 days | Experimental | Other: Cysteine/methionine deprivation (CMD) diet for 2 daysParticipants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 2 days. |
| Cohort B: Radiation Therapy 4 days | Experimental | Other: Cysteine/methionine deprivation (CMD) diet for 4 daysParticipants will undergo radiation therapy and receive a a cysteine/methionine deprivation (CMD) diet for 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of consent.
- Karnofsky Performance Status of ≥ 60 assessed at diagnosis
Key exclusion criteria (5 listed)
- Active infection requiring systemic therapy.
- Any active disease that may be associated with unacceptable anesthetic/operative risk.
- Pregnant or breastfeeding
- Subjects with prior brain metastasis.
- Transfusion within 7 days of diet initiation
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 |
|---|---|---|
| Normal dietParticipants receive normal diet. | Other | Cohort A: Surgery Control, Cohort B: Radiation Therapy Control |
| Cysteine/methionine deprivation (CMD) diet for 2 daysParticipants receive cysteine/methionine deprivation (CMD) diet for 2 days. | Other | Cohort A: Surgery Diet Restriction 2 days, Cohort B: Radiation Therapy 2 days |
| Cysteine/methionine deprivation (CMD) diet for 4 daysreceive cysteine/methionine deprivation (CMD) diet for 4 days. | Other | Cohort A: Surgery Diet Restriction 4 days, Cohort B: Radiation Therapy 4 days |
Primary outcome
Change in systemic glutathione metabolites
Time frame: Baseline and up to 4 days
Systemic glutathione metabolite levels in blood and urine will be assessed before and after a 2-day randomized assigned diet (normal or Cysteine and methionine deprivation (CMD)) diet. Measurements will be obtained using laboratory assays and Magnetic resonance (MR) spectroscopy. Analyses will be conducted overall and stratified by patients scheduled for standard-of-care (SOC) radiation therapy or surgery.
6 secondary outcomes
Change in systemic glutathione metabolites
Time frame: Baseline and up to 6 days
Change in tumor tissue glutathione metabolites
Time frame: At time of surgical resection and up to 6 days
Compliance with assigned diet regimen
Time frame: Baseline and up to 6 days.
Safety of normal or Cysteine and methionine deprivation diet
Time frame: Up to 30 days
Progression-Free Survival (PFS)
Time frame: 1 year
Overall Survival
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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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.
Dominique Higgins, MD, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet, Cysteine/methionine deprivation (CMD) diet for 2 days and Cysteine/methionine deprivation (CMD) diet for 4 days in people with Glioblastoma Multiforme and Recurrent Glioma, run by UNC Lineberger Comprehensive Cancer Center 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 28 Apr 2026. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in systemic glutathione metabolites (time frame: Baseline and up to 4 days). 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 28 Apr 2026.