Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor SurgicallyNCT04488783
Potentiation of Chemotherapy in Brain Tumors by Zinc
A study testing zinc and ascorbate in people with Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Glioblastoma (GB) is the most common and aggressive type of primary malignant brain tumor in adults. Despite advances in surgical resection, radiotherapy and chemotherapy, prognosis remains very poor. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically
- What is being tested?
- zinc and ascorbate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jul 2020to 30 Dec 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females,
- age ≥ 18 years old,
- newly diagnosed GBM, Karnofsky performance status of ≥ 70,
- after partial resection or gross tumor resection (GTR) who recovered from surgical resection.
Who cannot join
- GB patients with less than 20% of tumor removed,
- Prior treatment for GB (other than surgical resection),
- any known malignancy outside of the brain in the last 5 years,
- in ability to swallow drugs.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Ruty Shai, Ph.D, 972543938318, ruty.shai@sheba.health.gov.il
Ruty Shai, Ph.D
About this study
Glioblastoma (GB) is the most common and aggressive type of primary malignant brain tumor in adults. Despite advances in surgical resection, radiotherapy and chemotherapy, prognosis remains very poor. Temozolomide (TMZ) as an alkylating agent has become part of GBM management but it has contributed only marginally to prolongation of life in GBM patients. Our aim is to evaluate the therapeutic potential of the trace element zinc to facilitate temozolomide tumor cell toxicity in GBM. P53 gene is inactive/mutant in most of these patients which may affect the resistance to apoptosis of tumor cells by chemotherapy. Zinc (Zn) has a crucial role in the biology of p53, in that p53 binds to DNA through a structurally complex domain stabilized by zinc atom. We have shown that the cytotoxic activity of TMZ is substantially increased with the addition of zinc in vitro with GBM cell lines as well as in vivo, with intracranial GBM xenografts. Numerous studies of zinc in animal models and in human subjects support its use in the treatment and possibly the prevention of cancer. Zinc has been consumed by the public as an essential mineral (and thus is category A drug) in concentrations which allows this effect with Temozolomide. Vitamin C could add to this by priming the immune system for lymphocyte- linked cancer killing. The vitamin c increases the number of tumor infiltrating lymphocytes and enhances the activation of the immune system.We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of zinc and vitamin C.
Read the detailed description
We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of daily zinc. We will follow the toxicity, Progression free survival and overall survival of this group of patients. We hope to demonstrate the anti-tumor activity of zinc that will enhance the activity of temozolomide chemotherapy in adult glioblastoma patients. We will also follow the safety and monitor quality of life during treatment. In this study, we will compare results of patients receiving zinc to historical patient data. We will review patient portfolios with GB tumors that received treatment as the subjects in this study in the last five years before the study began. Collecting the data and separating the identified data from the file in a way that cannot be retrieved in any way will be done by a staff member from Dr Ruty Shai's laboratory who is authorized to open medical files. We will adjust the age and number of patients in each gender. Data collected: date of birth, age of disease development, gender, data after receiving treatment: Progression free survival and overall survival of this group of patients, side effects, and quality of life.
- Conditions
- Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically
- Being tested
- zinc and ascorbate
- Keywords
- GBM, glioblastoma, zinc, vitamin C
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc and ascorbateDietary supplement
oral zinc and ascorbate
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma patients | Experimental | newly diagnosed GB who underwent at least partial resection of the tumor surgically Receives: Dietary Supplement: zinc and ascorbate |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
Measured: year 1
overall survival (OS)
Measured: year 2
Secondary outcomes (3)
Tcell count
Blood test
Measured: year 2
Level of Interleukin 6
Interleukin 6 and Tumor Necrosis Factor quantification
Measured: year 2
Tumor Necrosis Factor quantification
Blood test
Measured: year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start30 Jul 2020 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor SurgicallyStudies of the same condition, open and under way.
- More trials run by Sheba Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Leor Zach, MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488783
- Sponsor's protocol ID
- 4266-17-SMC
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentiation of Chemotherapy in Brain Tumors by Zinc
- ClinicalTrials.gov ID
- NCT04488783
- Acronym / sponsor ID
- 4266-17-SMC
- Conditions
- Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically
- Keywords
- GBM, glioblastoma, zinc, vitamin C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 30 Jul 2020 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 Jul 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.
Glioblastoma (GB) is the most common and aggressive type of primary malignant brain tumor in adults. Despite advances in surgical resection, radiotherapy and chemotherapy, prognosis remains very poor. Temozolomide (TMZ) as an alkylating agent has become part of GBM management but it has contributed only marginally to prolongation of life in GBM patients. Our aim is to evaluate the therapeutic potential of the trace element zinc to facilitate temozolomide tumor cell toxicity in GBM. P53 gene is inactive/mutant in most of these patients which may affect the resistance to apoptosis of tumor cells by chemotherapy. Zinc (Zn) has a crucial role in the biology of p53, in that p53 binds to DNA through a structurally complex domain stabilized by zinc atom. We have shown that the cytotoxic activity of TMZ is substantially increased with the addition of zinc in vitro with GBM cell lines as well as in vivo, with intracranial GBM xenografts. Numerous studies of zinc in animal models and in human subjects support its use in the treatment and possibly the prevention of cancer. Zinc has been consumed by the public as an essential mineral (and thus is category A drug) in concentrations which allows this effect with Temozolomide. Vitamin C could add to this by priming the immune system for lymphocyte- linked cancer killing. The vitamin c increases the number of tumor infiltrating lymphocytes and enhances the activation of the immune system.We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of zinc and vitamin C.
Detailed description
We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of daily zinc. We will follow the toxicity, Progression free survival and overall survival of this group of patients. We hope to demonstrate the anti-tumor activity of zinc that will enhance the activity of temozolomide chemotherapy in adult glioblastoma patients. We will also follow the safety and monitor quality of life during treatment. In this study, we will compare results of patients receiving zinc to historical patient data. We will review patient portfolios with GB tumors that received treatment as the subjects in this study in the last five years before the study began. Collecting the data and separating the identified data from the file in a way that cannot be retrieved in any way will be done by a staff member from Dr Ruty Shai's laboratory who is authorized to open medical files. We will adjust the age and number of patients in each gender. Data collected: date of birth, age of disease development, gender, data after receiving treatment: Progression free survival and overall survival of this group of patients, side effects, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma patients | Experimental | Dietary Supplement: zinc and ascorbatenewly diagnosed GB who underwent at least partial resection of the tumor surgically |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females,
- age ≥ 18 years old,
- newly diagnosed GBM, Karnofsky performance status of ≥ 70,
- after partial resection or gross tumor resection (GTR) who recovered from surgical resection.
Key exclusion criteria (4 listed)
- GB patients with less than 20% of tumor removed,
- Prior treatment for GB (other than surgical resection),
- any known malignancy outside of the brain in the last 5 years,
- in ability to swallow drugs.
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 |
|---|---|---|
| zinc and ascorbateoral zinc and ascorbate | Dietary supplement | Glioblastoma patients |
Primary outcome
progression free survival (PFS)
Time frame: year 1
overall survival (OS)
Time frame: year 2
3 secondary outcomes
Tcell count
Time frame: year 2
Level of Interleukin 6
Time frame: year 2
Tumor Necrosis Factor quantification
Time frame: year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc and ascorbate in people with Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically, run by Sheba Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Jul 2020. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruty Shai, PhD (972-543938318, ruty.shai@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: year 1). 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 28 Jul 2020.