Recurrent GlioblastomaPhase 1ERGONCT00575146
Ketogenic Diet for Recurrent Glioblastoma
A Phase 1 study testing TAVARLIN in people with Recurrent Glioblastoma, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- TAVARLIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2007to Feb 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age >= 18 years
- histological diagnosis of glioblastoma or gliosarcoma
- on MRI measurable tumor
- interval of at least 6 months after primary resection
- completed radiotherapy, interval of at least 3 months after completion of radiotherapy
- relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient
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- Karnofsky-Index >= 60%, ECOG <= 2
- life expectancy of at least 12 weeks
- creatinine <= 1.5 mg/dl, urea <= 50 mg/dl
- INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value
Who cannot join
- bowel obstruction or subileus
- diabetes mellitus, HbA1c > 6,1 %
- heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation
- acute infection
- conditions that may strongly reduce compliance to the diet or increase risk of the diet
- dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Senckenberg Institute of Neurooncology
Frankfurt, 60528
Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen
Tübingen, 72076
About this study
Official title: Ketogenic Diet for Patients With Recurrent Glioblastoma
To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma
Read the detailed description
Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
- Conditions
- Recurrent Glioblastoma
- Being tested
- TAVARLIN
- Keywords
- glioblastoma, ketogenic diet
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVARLINDietary supplement
ketogenic diet, dietary supplementary products provided by TAVARLIN
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ketogenic diet Receives: Dietary Supplement: TAVARLIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
percentage of patients who discontinued diet due to intolerability
Measured: until progression for up to 12 months
Secondary outcomes (5)
Progression-free-survival
measured by Macdonald-Criteria
Measured: until progression for up to 12 months
Overall Survival
Participants were followed until reported death or last contact until 05/2011
Measured: death/last contact, an average of about 1 year
Frequency of Seizures
Measured: while on study treatment for up to 12 months
Ketosis
Measured: while on study treatment for up to 12 months
Quality of Life
Measured: while on study treatment for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Evomed MedizinService GmbH
- Responsible party
- Principal investigator, J. Rieger, University Hospital Tuebingen
- Investigators
- Johannes Rieger, MD, Principal investigator, Senckenberg Institute of Neurooncology, University of Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575146
- Sponsor's protocol ID
- ERGO
- Acronym
- ERGO
- Status last verified
- Apr 2014
- First submitted
- 17 Dec 2007
- Last updated
- 2 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rieger J, Bahr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kammerer U, Coy JF, Weller M, Steinbach JP. ERGO: a pilot study of ketogenic diet in recurrent glioblastoma. Int J Oncol. 2014 Jun;44(6):1843-52. doi: 10.3892/ijo.2014.2382. Epub 2014 Apr 11.
PubMed 24728273
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet for Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT00575146
- Acronym / sponsor ID
- ERGO / ERGO
- Conditions
- Recurrent Glioblastoma
- Keywords
- glioblastoma, ketogenic diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Evomed MedizinService GmbH
- Study start
- Dec 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Posted 13 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma
Detailed description
Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: TAVARLINketogenic diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age >= 18 years
- histological diagnosis of glioblastoma or gliosarcoma
- on MRI measurable tumor
- interval of at least 6 months after primary resection
- completed radiotherapy, interval of at least 3 months after completion of radiotherapy
Key exclusion criteria (6 listed)
- bowel obstruction or subileus
- diabetes mellitus, HbA1c > 6,1 %
- heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation
- acute infection
- conditions that may strongly reduce compliance to the diet or increase risk of the diet
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 |
|---|---|---|
| TAVARLINketogenic diet, dietary supplementary products provided by TAVARLIN | Dietary supplement | 1 |
Primary outcome
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
Time frame: until progression for up to 12 months
percentage of patients who discontinued diet due to intolerability
5 secondary outcomes
Progression-free-survival
Time frame: until progression for up to 12 months
Overall Survival
Time frame: death/last contact, an average of about 1 year
Frequency of Seizures
Time frame: while on study treatment for up to 12 months
Ketosis
Time frame: while on study treatment for up to 12 months
Quality of Life
Time frame: while on study treatment for up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24728273Rieger J, Bahr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kammerer U, Coy JF, Weller M, Steinbach JP. ERGO: a pilot study of ketogenic diet in recurrent glioblastoma. Int J Oncol. 2014 Jun;44(6):1843-52. doi: 10.3892/ijo.2014.2382. Epub 2014 Apr 11.
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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.
Johannes Rieger, MD principal investigator
Senckenberg Institute of Neurooncology, University of Frankfurt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAVARLIN in people with Recurrent Glioblastoma, run by University Hospital Tuebingen at 2 sites in Germany.
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 10 inclusion and 6 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 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability (time frame: until progression for up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00575146, which also lists 1 linked publication.
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 2 May 2014.